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Acta of Shoulder and Elbow Surgery by http://asesjournal.com/ is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
ISSN 2457-0338
Acta of Shoulder and Elbow Surgery by http://asesjournal.com/ is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
ISSN 2457-0338
Why a new Shoulder and Elbow Journal?
/0 Comments/in Vol 1| Issue 1| Oct-Dec 2016 /by ASESADMIN2016Acta of Shoulder and Elbow Surgery | Volume 1 | Issue 1 | Oct-Dec 2016 | Page 2-3 | José Carlos Garcia Jr.
Author: José Carlos Garcia Jr. [1].
[1] NAEON-Santa Catarina Hospital
Address of Correspondence
Dr. Jose Carlos Garcia Jr., MD, MSc, PhD
NÆON-Hospital Santa Catarina-SP-Brazil
Email: jose.cjunior@hsl.org.br
Most Shoulder and Elbow Surgery journals are written in a far beyond context than most developing countries are up to. Distinguished features related to developed countries impact on the way people make surgeries, use materials and even make researches.
Availability of materials and devices, costs, local regulatory agencies and many other points need to be considered when talking about developing countries.Sometimes solutions adapted for these countries will not make sense for people of developed countries, with a different reality.
Then researches using some of the developing countries’ solutions will don’t make sense for reviewers from developed countries.
In the opposite side, discussing these solutions may be very important to develop shoulder and elbow surgery in developing countries. It is not about making second class researches, it is about looking researches within a different way of view. The first answer therefore is: We made this journal because we need to discuss issues adapted to our reality. We need to demonstrate results that can improve techniques possible to be reproduced all over the world. Consequently we will need to makeresearches that can be more suitable to our day by day. It does not mean bad research or bad results, it means a different way to make good things.
The second answer is: Because low cost innovations will make the world better and more equal. This journal has begun with an editorial board capable of diffusing the most recent concepts at no cost, making data easy to spread and replicate.
The third answer is: Considering that, in general, developing countries need some degree of refinement in shoulder and elbow surgery yet, transformations will be required. A rational step towards this new paradigm is an intersection of the two worlds, developed and developing countries.
This journal aims to promote this intersection by using new surgical techniques, researches and symposiums. As one wants to go further, one must have a general panorama of what is going on around to better know where to go. That is the purpose of the Current Concepts section of this journal whose content is a summary of the main journals of Shoulder and Elbow Surgery. It is not intend to explore the deepness of all research published but just a general panorama. Our concept is by accessing just this journal one can know what is going on around the world of Shoulder and Elbow Surgery and also have access to researches, symposiums and many other academical papers.
Combining all these characteristics in a single journal is essential to make surgeons updated and open minded to innovations.
This journal also begins by bringing a new concept to understand researches within the surgical field, it uses new ideas from IDEAL-Collaboration, Oxford, aiming to improve research methodology on surgical field.
We hope Acta of Shoulder and Elbow Surgery can be the new channel for all orthopedic surgeons interested in the area.
You are invited to be our reader, contributor and friend.
Warm Regards
José Carlos Garcia Jr.
Editor-in-Chief
José Carlos Garcia Jr., MD
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A Comprehensive Review of Triple Disruptions of the Superior Shoulder Suspensory Complex and Case Report
/0 Comments/in Vol 1| Issue 1| Oct-Dec 2016 /by ASESADMIN2016Acta of Shoulder and Elbow Surgery | Volume 1 | Issue 1 | Oct-Dec 2016 | Page 56-61 | Mário Henrique Lobão Gonçalves, Jose Carlos Garcia Jr
Authors: Mário Henrique Lobão Gonçalves [1], Jose Carlos Garcia Jr [1]
[1] NAEON-Santa Catarina Hospital
Address of Correspondence
Dr. Jose Carlos Garcia Jr., MD, MSc, PhD
NÆON-Hospital Santa Catarina-SP-Brazil
Email: jose.cjunior@hsl.org.br
Abstract
Introduction: The Superior Shoulder Suspensory Complex (SSSC) is a ring-shaped structure that plays important role in stability, biomechanics and overall function of the shoulder (3). Triple disruptions (TD) of SSSC during a single trauma are extremely rare events. This paper presents a rare case of TD and a comprehensive review of the literature.
Case report: A 30-year-old man presented a combination of fracture of the base of coracoid process, AC joint dislocation and fracture of the spine of scapula with reduction of subacromial space. He was treated surgically by a dual approach, reducing and fixing all three lesions with an excellent outcome at 3 months after surgery.
Discussion: After literature search we found only 41 multiple SSSC injuries. The most prevalent structure injured was the coracoid (70.73%). When considering possible bias for diagnosing TD, like fractures of mid-shaft clavicle, the number of “true” TD decreased to 23. This significant number of misdiagnosis calls attention to confusion between the concepts of floating shoulder and SSSC, which reflects in low reliability of diagnosing (41.46%).
Conclusion: Although triple disruptions of the SSSC are very rare, they may be becoming more frequent due to an increasing high-energy accidents caused by motor vehicles. As proposed by Goss, the treatment of these lesions must fix no less than the total number of SSSC structures injured minus one.
Key words: Superior Shoulder Suspensory Complex, Double disruptions, Acromion, Coracoid, Acromioclavicular, Floating Shoulder.
Introduction
The Superior Shoulder Suspensory Complex (SSSC) is a ring-shaped structure that plays important role in stability, biomechanics and overall function of the shoulder (3). It comprises the distal end of clavicle, acromioclavicular (AC) joint, acromion, glenoid and coracoid processes, and coracoclavicular ligaments. Disruptions of the SSSC in a single spot due to an AC joint dislocation are very common injuries often treated conservatively as stability of SSSC structure remains intact. Double disruptions, like AC joint dislocation together with coracoclavicular ligaments tear, destabilize SSSC ring and are susceptible to delayed union, malunion and nonunion, as well as adverse long-term functional limitations to the shoulder (5). Therefore, double brakes usually require operative treatment to regain stability of the system (3,5). Triple Disruptions (TD) of SSSC during a single trauma are extremely rare events. In fact, only 41 cases have been reported so far (8,9,10,13,15,16,17,20,21,24,25). Although some authors published injuries claiming to be TD, many of them are not true TD, but in fact double disruptions (DD) (13,17,20,21). This paper presents a case of a patient presenting combined fractures of coracoid and scapular spine together with an acromioclavicular separation after a severe motorcycle accident. This injury pattern was only reported once before (20). It is also the first report of a triple disruption of the SSSC in South America.
Case Report
A 30-year-old man without previous shoulder injury experienced direct trauma to his shoulder during a motorcycle crash. He was taken to the emergency care center with a chief complaint of intense pain to his left shoulder. Although he had suffered a head trauma and did not remember details about the accident, initial evaluation and CT scans excluded major head, spine or vital organs injuries. Physical exam revealed tenderness, swelling and a bruise at the top of his left shoulder, pain to palpation of AC joint and crepitation over the anterior aspect of shoulder. Although no definite neurovascular abnormalities on the left upper extremity were found, there were important range of movement limitations due to pain, as follow: active shoulder forward flexion/abdution of 90º/80º, reaching 110º/90º passively; 30º external rotation; and internal rotation up to the sacrum.
Initial left shoulder radiographs showed a fracture of the base of coracoid process (Ogawa classification type I) (19), a 15mm AC joint dislocation and a fracture of the spine of scapula with reduction of subacromial space (Kuhn classification type III (11)) [Figure 1]. A left shoulder computed tomography scan with three-dimentional bone reconstruction was done to better understand fracture pattern and to plan surgical treatment. It showed a 27º inferior tilt of distal scapular spine and acromion significantly reducing the subacromial space, and a 38º rotational displacement of the coracoid fragment. Scapular spine fracture line clearly did not reach the spinoglenoid notch, classified as type I of Ogawa&Naniwa classification (18), which means less risk of suprascapular nerve being damaged. [Figure 1]. Surgery for SSSC complex repair was undertaken on the 7th day post-injury. Under general anesthesia, with patient in beach-chair position, a longitudinal approach over the spine of scapula extending to lateral acromion was adopted. Suprascapular nerve was identified and the scapular spine was fixed using a reconstructive 3.5mm plate and six cortical screws. Intra-operative fluoroscopy just after this first stage continued to show displacement of AC joint and coracoid fracture. So a second ‘saber-cut’ approach had to be done in the anterior aspect of the left shoulder in order to access both coracoid and AC joint. Lacerated meniscus was removed allowing AC joint reduction and provisional fixation using a 2.5mm Steinmann pin oriented from distal clavicle to the spine of scapula just medial to fracture site. Both coracoclavicular ligaments were intact when inspected. Finally, the coracoid fracture was reduced and fixed using a 3.5mm cannulated screw under fluoroscopy. After meniculous reattachment of deltoid, the wound was closed in layers. A CT scan was repeated on the first day post-operatively to evaluate correct position of the coracoid screw [Figure 2]. Postoperatively, the patient received a continuous sling. Active hand, wrist and elbow motion were encouraged since immediately after surgery but shoulder was restrained until 6 weeks after surgery, when the Steinmann pin was removed and shoulder rehabilitation started. Both factures healed and a full painless range of shoulder motion was obtained in a 3-month period. The patient was followed for 2 years and had excellent functional outcome at the last follow-up, returning to sports activities unhindered [Figure 2].
Discussion
Fractures of the scapula result of high-energy traumatic events, like motor vehicles accidents and falls from heights (1). They affect mainly 30 to 45 year-old male adults (1). These relatively rare injuries account for 3-5% of all fractures involving the shoulder girdle and 1% of all fractures. Direct trauma to the lateral aspect of shoulder is the most common mechanism of injury causing scapular fractures (1). Coracoid fractures account for 2-5% of all scapular fractures. Ogawa et al. (20) reported 35 coracoid fractures and found among them 67% of double disruptions (DD) of the SSSC and 28% of triple disruptions (TD) in a 34 year-time period (1974-2008). It shows how rare TD lesions are. Our study analysed 41 TD and coracoid was found to be the most SSSC structure fractured in these injuries (70.73%) [Table]. Acromion fractures account for near 8% of all scapular fractures. In our review we found acromion fractures in 56.10% of TD. It was the second most prevalent SSSC structure injuried among TDs, tied with AC dislocations [Table]. As up to 90% of all scapula fractures are non-displaced or minimally displaced and so they can be treated conservatively using slings or braces (1,4,5,23), it took long time until surgical treatment of scapula fractures has come to spotlight, which only occurred in the nineties. There has been a growing body of scientific literature around double disruptions of the SSSC and floating shoulder injuries lately, which indicates that these injuries may not be as rare as originally proposed (17). The Superior Shoulder Suspensory Complex (SSSC) was described by Goss in 1993 as an osteoligamentous ring located around distal clavicle and scapular junction, which have ultimate importance in shoulder biomechanics (3). It comprises the distal end of clavicle, acromioclavicular (AC) joint, acromion, superior glenoid and coracoid processes, and coracoclavicular ligaments (3). Isolated disruptions to the SSSC with minimal or moderate displacement, like AC dislocations grades I and II of Rockwood classification (23), do not affect stability of the SSSC ring allowing them to be successfully treated conservatively. On the other hand, double disruptions of the SSSC injuries make the SSSC ring unstable affecting shoulder biomechanics. They involve several combinations of injuries to SSSC structures deeply related to each other, whose treatment is still challenging. In the past, assessment of double disruptions of the SSSC was made in an isolated manner, which frequently took to inadequate treatment since biomechanical correlation between SSSC structures was unknown. Then, Goss made these injuries easier to comprehend as he compared SSSC to a ring(3,4,5), where every structure of the ring correlates to each other to grant stability to the system. So, surgical treatment must restore at least one of the SSSC lesions in order to restore ring stability and, by doing that, it indirectly reduces and stabilizes the second break (3). Without proper surgical repair these injuries commonly evolve to delayed-union, nonunion or mal-union, leading to a long-term dysfunctional shoulder (3). However, there is still missing trials that approach long-term shoulder dysfunction after conservative and surgical treatment for double disruptions of the SSSC. Ganz and Noesberger (6) described in 1975 a combined ipsilateral fracture of mid shaft clavicle and scapula neck, known as “Floating Shoulder”. Although described much earlier than the SSSC, this concept poses confusion to the diagnosis of SSSC lesions. When one tries to mix Floating Shoulder to the SSSC concept, it is common to see misdiagnosis. Mistakes usually happen when one consider mid-shaft clavicles as a part of the SSSC.
It is not rare to see misdiagnosed DD by including scapula body and glenoid intrarticular fractures as well. Most articular glenoid fractures do not disrupt the SSSC. In fact, the only ones that do affect the SSSC are Goss-Ideberg types III and variants(4). Triple disruptions (TD) of the SSSC are indeed very rare injuries. Generally they are much more unstable than a double disruption. So they require surgical stabilization of at least two structures in order to restore stability of the ring. Although there is none evidence-based guidelines for much complex injuries, most surgeons follow the same principles proposed by Goss for treatment of DD of the SSSC. Almost all published studies addressing TD injuries are case reports of surgical treatment and they have demonstrated good outcomes so far. Only one case report treated conservatively a 74-year-old men who, despite oriented about the severity of his lesions (AC dislocation, acromion, coracoid and posterior glenoid border fractures), decided not to operate and presented reasonable functional outcomes after one year(25). Although our case report did not presented any associated lesion, several reports mention associated injuries to SSSC disruptions, like rib fractures, proximal humerus fractures, spinal trauma, braquial plexus and peripheral nerves injuries, and hemothorax. As some of these are life-threatening injuries, they might contribute to the low prevalence of TD of the SSSC. After a comprehensive literature search we found eleven studies about multiple (more than two) SSSC injuries(8,9,10,13,15,16,17,20,21,24,25). Most papers describe the author’s experience of treating SSSC lesions through various techniques (8,10,15,16,24). From the 11 studies analysed in this study, 8 of them (72.72%) are case reports (8,9,10,13,15,16,24,25) and all but one describe surgical treatment (25). The largest series found include 15 patients with greater than two disruptions of the SSSC (12 triple and 3 quadruple ruptures). It is the only level IV therapeutic study available until now(17). All injuries presented on that paper affected mostly men with a mean age of 35 years. They resulted from motorcycle and snowmobile accidents, motor vehicle collisions and falls from heights. Considering the high-energy of trauma involved on TD of the SSSC, some authors believe these injuries could not be caused by a single impact to the shoulder, but rather they must result from multiple impacts during one severe high-energy trauma event. It also explains the significant number of concomitant associated injuries found on that study (87%), which delayed surgical treatment of the SSSC in mean 23 days. Such complex traumas demanded operative treatment for all 15 patients and 67% of them required more than 1 surgical approach to adequately restore alignment and stability of the SSSC. Post-operative functional scores (DASH and SF-26) and shoulder range of motion were good at mean follow-up of 30.7 months, with very low rate of complications, except for a mean overall decrease of 64.33% in shoulder strength for forward flexion, abduction and external rotation compared to the non-injured side. After plotting information from all 11 studies analysed, a total of 41 multiple disruptions of the SSSC were found. 35 (85.36%) were initially considered triple disruptions (TD) and 6 (14.64%) quadruple disruptions (QD). The most prevalent SSSC structure injured on these complexes traumas was the coracoid process (70.73%), followed by acromion (56.10%), clavicle (56.10%) and AC joint (56.10%). TD involving fractures of scapula spine, like the one presented on this case report, were the most rare, with only 2 cases reported (4.88%). Before this, only one similar case report had been published. When taking into consideration possible bias for diagnosing TD and QD of the SSSC, like fractures of mid-shaft clavicle, scapula body and glenoid cavity fractures, the number of “true” TD and QD decreased to 23 and 1 respectively. The main cause of misdiagnosis occurs when mid-shaft clavicle fractures are considered as an SSSC rupture (62.50%). In fact, according to Goss, mid-shaft clavicle fractures are not considered disruptions of the SSSC, neither scapula body (23.53%) nor glenoid edge fractures (13.97%). The significant number of misdiagnosed TD (52.17%) and QD (83.33%) calls attention to the very confusing interaction between the concepts of floating shoulder and the SSSC, which reflects in low reliability of diagnosing multiple simultaneous SSSC structures disruptions (41.46%). Le Coq et al (13) published in 2001 the first case report of a triple disruption of the SSSC. It was a combination of fractures of acromion and coracoid processes and a non-displaced mid-shaft clavicle fracture, which by definition is not a SSSC structure. So, in fact, it was a double disruption (DD) instead of a “true” triple disruption as proposed. The fact that he only had to fix the coracoid to obtain stability of the shoulder joint confirms the SSSC ring was only disrupted in two sites. Other authors also committed similar errors(9,20,21). Recently, Kim et al (9) reported a combination of AC dislocation, coracoid and mid-shaf clavicle fractures as a triple disruption, but that was in fact a DD. Toft et al (25) published the first QD of the SSSC treated non-operatively, but among the ruptures described there was an articular glenoid edge fracture that, despite needed fixation, is not a true SSSC disruption. From the 6 cases of QD ever published(17,21,25), only one is a “true” QD (17) and it is still one of a kind. It calls attention to the extreme rarity of QD lesions. Perhaps the reason for that is the supreme energy necessary to disrupt the SSSC ring in four concomitant sites.
Limitations
Due to the rarity of triple disruptions, like in the others case reports, this case exhibits a possible surgical treatment based on techniques previously described for double ruptures of the SSSC. None technique presented can be considered as ‘gold standard’, neither superior to any other treatment option. Despite this case showed excellent outcomes in a 2-year follow-up after surgery, there is no long-term guarantee that this patient will preserve a functional and pain-free shoulder. At last, the low reliability in making a correct diagnosis of multiple concomitant SSSC disruptions presented in this comprehensive revision of the literature overclouds even more the understanding of such complex injuries and slow the settlement of treatment guides.
Conclusion
Although triple disruptions of the SSSC are very rare, they may be becoming more frequent due to an increasing high-energy accidents caused by motor vehicles. CT scans are important tools to better understand injuries patterns and to plan surgical treatment. Goss’ SSSC principles should be followed straightly in order to avoid misdiagnosis of triple and quadruple disruptions of the SSSC. Treatment of these lesions must also follow Goss’ principles, taking into consideration the scarce treatment trials available. The number of structures to be fixed may vary in each case, but it must not be less than the total number of SSSC structures injured minus one.
References
1. Ada JR, Miller ME. Scapular fractures. Analysis of 113 cases. Clin Orthop Relat Res. 1991; 269:174–80.
2. Egol KA, Connor PM, Karunakar MA, et al. The floating shoulder: clinical and functional results. J Bone Joint Surg Am. 2001; 8:1188-1194.
3. Goss TP. Double disruptions of the superior shoulder complex. J Orthop Trauma. 1993; 7:99-106.
4. Goss TP, Owens BD. Fractures of the Scapula. In: Rockwood CA Jr, Matsen FA, editors. The Shoulder. 4th ed. Vol. 1. Philadelphia, PA: Saunders/Elsevier. 2009; pp333–80.
5. Goss TP. Scapular fractures and dislocations: Diagnosis and treatment. J Am Acad Orthop Surg. 1995; 3:22–33.
6. Ganz R, Noesberger B. Treatment of scapular fractures. Heffe Unfalheikd. 1975; 126:59-62
7. Hak DJ, Johnson EE: Avulsion fracture of the coracoid associated with acromio-clavicular dislocation. J Orthop Trauma. 1993; 7:381-383.
8. Jung CY, Eun IS, Kim JW, Ko YC, Kim YJ, Kim CK. Treatment of triple fracture of the superior shoulder suspensory complex. J Korean Orthop Assoc. 2011; 46:68–72.
9. Kim BK, Dan J. A triple disruption of the superior shoulder suspensory complex mstaken for a Double disruption: a case report. Arthrosc Orthop Sports Med. 2016; 3:45-48.
10. Kim SH, Chung SW, Kim SH, Shin SH, Lee YH. Triple disruption of the superior shoulder suspensory complex. Int J Shoulder Surg. 2012; 6:67-70.
11. Kuhn JE, Blasier RB, Carpenter JE: Fractures of the acromion process: A proposed classification system. J Orthop Trauma. 1994; 8:6-13.
12. Kurdy NM, Shah SV: Fracture of the acromion associated with acromioclavicular dislocation. Injury . 1995; 26:636-637.
13. Lecoq C, Marck G, Curvale G, Groulier P. Triple fracture of the superior shoulder suspensory complex. Acta Orthop Belg. 2001; 67:68–72.
14. Lim KE, Wang CR, Chin KC, Chen CJ, Tsai CC, Bullard MJ. Concomitant fracture of the coracoid and acromion after direct shoulder trauma. J Orthop Trauma. 1996; 10:437–439.
15. Liu AJ, Chen PJ, Shen PW. Triple injury to the superior shoulder suspensory complex. Form J Musc Dis. 2013; 4:81-83.
16. Mariño IT, Martin Rodríguez I, Mora Villadeamigo J. Triple fracture of the shoulder suspensory complex. Rev Esp Cir Orthop Traumatol. 2013:57:371-4.
17.Mulawka B, Jacobson AR, Schoroder LK, Cole PA. Triple and quadruple disruption of the superior shoulder suspensory complex. J Orthop Trauma. 2015; 29:264-70.
18. Ogawa K, Naniwa T: Fractures of the acromion and the lateral scapular spine. J Shoulder Elbow Surg. 1997; 6:544-548.
19. Ogawa K, Yoshida A, Takahashi M, Ui M. Fractures of the coracoid process. J Bone Joint Surg Br. 1997; 79:17–9.
20. Ogawa K, Matsumura N, Ikegami H. Coracoid fractures: therapeutic strategy and surgical outcomes. J Trauma Acute Care Surg. 2012; 72:E20-E26.
21. Oshima M, Nakagawa Y, Mondori T. Complex injury patterns of the shoulder girdle three or four site injury. Shoulder Joint. 2003; 27:555-559.
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Cochrane’s Shoulder-and-Elbow Systematic Reviews Issues: Mistrustful Impact of Evidence
/0 Comments/in Vol 1| Issue 1| Oct-Dec 2016 /by ASESADMIN2016Acta of Shoulder and Elbow Surgery | Volume 1 | Issue 1 | Oct-Dec 2016 | Page 47-55 | Jose Carlos Garcia Jr, Mario H L Gonçalves, Eduardo F. Cordeiro, Luiz F S Fink, Alvaro M Cardoso Jr, Mauricio P Raffaelli, Maurício S Fade.
Authors: Jose Carlos Garcia [1], Mario H L Gonçalves [1], Eduardo F Cordeiro [1], Luiz F S Fink [1], Alvaro M Cardoso [1], Mauricio P Raffaelli [1], Maurício S. Fade [1]
[1] NAEON-Santa Catarina Hospital.
Address of Correspondence
Dr. Jose Carlos Garcia Jr., MD, MSc, PhD
NÆON-Hospital Santa Catarina-SP-Brazil
Email: jose.cjunior@hsl.org.br
Abstract
Introduction: Evidence-based guidelines are important for Medicine. However they have repeatedly failed in presenting conclusive evidence in surgical field. The reason is limited availability of well-designed scientific studies. In order to investigate limitations and their impact on Shoulder and Elbow Surgery field, we assessed data of Systematic Reviews (SRs) from the Cochrane Library database for risk of bias. Analysis of the 35 SRs assessed presented the following risk of bias: Comparable outcomes within SRs studies – 42.86%; Blinding – 40.80%; Sample size calculation – 7.43%; Missing valus handling – 16.14%; Adequate statistical analysis – 11.74%; Monitoring – 0.37%; and Meta-analysis data heterogeneity – 40.54%, showing that these papers have low methodological quality. This study may call attention of Shoulder and Elbow surgeons to aim in quality improvement, data comparability and reliability of primary trials and SRs. Future conjoint effort in defining and diffusing feasible standards for surgical trials must be made by local and international societies of surgical specialties.
Key Words: Shoulder, Elbow, Systematic Review, Methodological Quality.
Introduction
Evidence-based medicine is the source for the highest level of evidence and reliability, driving to better decision-making in medical practice25. Despite all advantages of this method, one must be aware of the difficulty in accessing nonpublished Clinical Trials or Clinical Trials published in languages other than English, which are common limitations related to all Systematic Reviews (SRs) [29]. Clinical Trials whose statistical significance is not reached are frequently considered ‘second-class’ papers, being disregarded by clinical researchers and not accepted for publication by reviewers12. The absence of inclusion of these data into the SRs and meta-analysis leads to biased interpretations and conclusions40. The way SRs are conduted and how results are extracted from primary studies vary among different areas of medicine. Each different area has its particularities and limitations for research. It is very clear when we compare clinical and surgical trials. Following are the main particularities that preclude surgical field research to be conducted in similar way to clinical ones: (1) Impossibility of double blinding – some trials compare techniques that do not allow true blinding. For example, scars inherent to open surgery technique cannot be hidden when comparing it to an endoscopic procedure. (2) Learning curve – unlike of ministering manufactured pills, surgical performance will depend on surgeon’s experience and it surely affect outcomes33,10. (3) Technological evolution of implants and devices – over time history showed us improvement in outcomes of endoscopic procedures over open ones due to progress of devices [27]. Also it is not adequate to compare procedures done with different generation of implants (4) Technique evolution – modification of some steps within the same technique can also impact learning curve and results. These and other characteristics make surgical research much more complex than those within clinical trials outside the surgical field. Recentely Orthopaedic Surgery evidence-based medicine has promptly grown in importance after publication of some pivot Randomised Controlled Clinical Trials (RCTs) [24]. However, most SRs failed to present enough evidence to establish a reliable Evidence-Based Practice Guideline because strict selective criteria for inclusion in SRs limited the number of RCTs in the meta-analysis. Methodological limitations, such as improper randomization40, absence of Intention-to-Treat analysis23, poor selection criteria [22] and lack of standardization of outcomes are pointed out as main causes of failure of Orthopedics’ and its subspecialties’ SRs [30,41]. Better and deeper understanding of these limitations may be key to improve both primary research and consequently SRs in orthopaedic surgery. Thus, better decisions based on the best evidence will be able to be made.
Methods
Study Design
This Systematic Review assesses Cochrane’s Systematic Reviews of Shoulder and Elbow. The authors are orthopaedic surgeons familiar with this field of knowledge. So Shoulder-and-Elbow subspecialty will represent orthopaedic surgery addressed in this study, following Descartes’ principle that “all complex matters need to be divided into many simpler parts in order to better focus on specific problems, thus creating greater possibilities of understanding and solving them”. As Cochrane Library is known as one of the most complete, important and reliable sources of SRs [13], a review of all Cochrane SRs related to shoulder-and-elbow subspecialty was conducted to better understand limitations and characteristics of RCTs and SRs related to orthopedics.
Search Strategy
Two strategies were used: (1) Cochrane website’s Search Tool – Medical Subject Headings (MeSH) terms searched: shoulder, elbow, scapula, humerus, cuff, ulna, epicondylitis and dislocation. The SRs that addressed the subspecialty of Shoulder-and-Elbow Surgery were chosen by assessing titles. (2) Direct search in Cochrane Bone, Joint and Muscle Trauma Group. Thereafter three senior specialized in should-and-elbow orthopaedic surgeons reviewed all abstracts identified and consensually withdrew duplicated papers, the ones that are not related to shoulder-and-elbow, studies that were just protocols, studies that were split into others and outdated ones. As inclusion phase is from utmost importance, five senior surgeons analysed all papers and consensually withdrew studies not related to at least one of the following topics: physical exam, clinical or surgical therapeutics of shoulder-and-elbow subspecialty.
Data Extraction
All data were extracted as consensus by three authors that assessed methodology of the selected SRs based on Cochrane’s Methodological Quality Assessment Tool [8,14,5,20,19] and Complementary Assessment of RCTs [40,41,43,15,39,11].
Measurement Tools
The Cochrane Musculosketal Group grades SRs’ evidence as: Platinum, Gold, Silver or Bronze levels, according to Cochane’s Methodological Quality Assessment. This has two different bias assessment tools: Surgical and Clinical, each specific for the nature of the SRs analysed. They comprise a judgement and support for each entry in a ‘Risk of bias’ table, where each entry addresses a specific feature of the study as low risk, high risk or unclear risk. For trials of clinical treatments, an eleven-item risk of bias assessment was used: randomization, allocation concealment, balance in baseline, blinding provider, co-interventions avoided, adherence acceptable, patient blinded, acceptable withdrawn, outcome assessor blind, timing of assessment comparable and Intention-to-Treat analysis [8,14,5,20,19]. For surgical treatment trials, a seven-item risk of bias was used assessing: randomization, allocation concealment, functional blinding, incomplete outcome (losses >20%), selective reporting, base-line balance and performance bias [8]. The Complementary Assessment of RCTs assesses other important points not considered by Cochrane’s tools. It was developed using important issues from CONSORT [11], COMET [32] and Cochrane Handbook [44] related to quality standards8. For each issue assessed there were five possible answer categories: yes, no, unclear, not-applicable (NA) and not-reported (NR). There are three sections: (1) Issues related to SRs – Less than 40% heterogeneity between primary trials within the review, which means low to moderate heterogeneity8; (2) Choice of Outcomes – if study present at least one outcome as ‘standard’ comparable at more than 50% of primary papers included in the review; (3) Issues related to primary studies in SRs – Choice of Target Population, Blinding, Sample Size (reduce type 2 error), Adequate Statistical Analysis (assessment of curves characteristicsto understand if data is parametric or non-paramentric, presence of standard deviations and standard errors, etc), Missing Values Handling (Intention-to-Treat or Per-Protocol), Data Entry Cautions (reading aloud, single data entry with cross-checks or double data entry) and Data Monitoring. Since clinical and surgical treatments present different patterns of assessment, the authors chose to stratify analysis through these two types of treatment to better understand differences between them. SRs that do not present any RCT were not removed. Instead they were assessed separately to better understand causes of withdrawal of primary papers.
Data Analysis/ Procedures
Variance with standard error, standard deviation and confidence intervals were not logical analysis for this review, once the entire population of Cochrane’s Shoulder-and-Elbow SRs was addressed. Statistical methods provide estimations with respect to a certain degree of uncertainty and results reflect all of the population of the SRs. Thus, this SR shows the ultimate results based on the whole data. Data for Cochrane Musculoskeletal Group’s primary trials were presented only descriptively.
Results for Cochrane’s Methodological Quality Assessment and Complementary Assessment of RCTs were presented in frequency through proportions and percentagens of risk of bias for each item stratified into subgroups. Papers withdrew from SRs, including SRs without meta-analysis, were analysed for most common reasons for withdrawal and data presented in frequency by absolute numbers. Results were stratified into the following groups: all SRs, Clinical SRs, Surgical SRs and SRs without meta-analysis.
Ethics
As this study comprises a secondary data analysis, University of Liverpool Ethics Committee, Santa Catarina Hospital and the Brazilian Government granted approval based on the fact that there was no risk to human subjects.
Results
Thrirty-eight SRs were included, 17 of them are surgical and 21 clinical. Of all surgical SRs, 2 did not present RCTs or quasi-randomised trials and therefore did not present meta-analysis. On the clinical group, one SR did not present meta-anaylisis.
Table 1: Results of Cochrane’s Methodological Quality Assessment tools for clinical SRs
SRs were assessed in 3 groups: whole 38 SRs, Clinical (20 SRs) and Surgical (15 Srs). According to Cochrane Musculoskeletal Group grade for primary trial, including SRs without meta-analysis, of all 38 SRs selected only one paper reached platinum level of evidence. Three SRs reached silver level, one with high risk of bias due to heterogeneous intervention and two low risk of bias. Three other SRs presented very limited evidence. Due to lack of any proper evidence others SRs could not be graded by Cochrane Musculoskeletal. Results of Cochrane’s Methodological Quality Assessment tools for clinical and surgical SRs are respectively shown on TABLES 1 and 2.
Table 3: Complementary Assessment analysed 9 topics looking for potential bias not considered on Cochrane’s Methodological Quality Assessment
Complementary Assessment developed by the authors analysed 9 topics looking for potencial bias not considered on Cochrane’s Methodological Quality Assessment. Results are shown on TABLE 3. Target Population topic assesses if patients were suitable for the proposed intervention and almost all SRs presented adequate target population. But 3 primary papers were conducted among militaries and were considered as potential bias. Heterogenity <40% and Comparable Outcomes were found in round 40% of the Srs. Blinding, as expected, showed a great difference between clinical (54,30%) and surgical (19,35%) papers. Sample Size Calculation, Statistical Analysis and Missing Values were presented in less than 20% of all SRs, what made us very concerned about reliability of results. Data Entry seems to be well difunded among SRs authors. All SRs analysed had reported it. However, none Primary Paper had it. Monitoring was the worst aspect taken into consideration by researchers. Only one SR (0,37%) had adequate monitoring and it was a clinical SR. Papers and SRs without meta-analysis were withdrawn and results are shown on TABLE 4, stratified by reason for exclusion.
Table 4: Papers and SRs without meta-analysis were withdrawn and stratified by reason for exclusion
Discussion
Cochrane’s Systematic Reviews are known by high standard and reliability. Many physicians have been using them as guide for the best evidence possible in certain fields of medicine. Despite they have proven to be effective to summarise results of trials in the Clinical field, they lack effectiveness in many Surgery trials. A commom complaint among surgeons is that SRs have not been able to provide reliable guidelines. Conclusions are repetitively similar in most of SRs: “There is limited evidence available from RCTs on the relative effectiveness of [a certain surgical treatment]”. Considering SRs analysed in this article were conduted in conformance with the high standards of Cochrane Collaboration, the absence of adequate evidence must be due to failure within primary papers and withdrawn ones. Of all reviewed SRs, we found a low rate of conclusiveness. Only one article reached the Platinum level of evidence according to Cochrane, showing that Shoulder-and-Elbow SRs have often failed to present enough evidence to establish reliable evidence-based practice guidelines41. Some authors stated that “absence of evidence is not evidence of absence”1. Therefore, the main cause of this lack of evidence may just be absence of data for establishing reliable results. The number of individuals necessary to suitably answer a research question may be more than those enrolled in the SR, making results not truly reliable. So, larger samples will lead trials to achieve narrower confidence intervals and high statistical power31. SRs may be guides to determine whether more studies are necessary or not to suitably answer a research question, as well as to determine what direction researchers need to follow in future trials, like sample sizing and research harms9. Deep analysis of the only Platinum-level SR found in this study showed: inclusion of a Silver-level primary study, only 50% of included papers had Intention-to-Treat, only 40% performed Sample Size Calculation and less than half of outcomes were comparable. So, despite having 90% of blinded primary papers and 70% of adequate statistical analysis, there is a lack of methodological quality that precludes adequate use of this data for meta-analysis. Less than 50% of SRs presenting at least one comparable outcome indicate an immediate necessity of discussion and standardization of outcomes among Shoulder and Elbow researchers. The Rowe scale37 was the most ‘popular’ (50%) specific outcome for shoulder instability within Cochrane’s SRs probably because it is simple, fast and reproductible. For rotator cuff interventions we found 3 major outcome assessment scores: UCLA21 (5 /14) – the oldest and most used; Constant35 (3/14) – mostly used in Europe; and ASES28 (1/14) – mostly used in North America. Perhaps if all future primary papers could standardize the use of all three outcome-scores in a definite timeframe, papers would certainly be more comparable all around the world. There is over emphasis in effectiveness within the SRs in expence of many times omitting safety information16. Indeed, medical decision follows a Paraconsistent logic pattern where positive and negative aspects are weighted to reach the best decision for each individual3. Thus, insufficient disclosure of safety aspects within a SR can overestimate effectiveness, driving to biased decisions regarding treatment. Simple methodological issues like Blinding presented remarkable antagonism within clinical and surgical fields of the same subspecialty. Realiable blinding was found in only 19.35% surgical RCTs in contrast to 61.14% clinical RCTs. Surgical approach, post-surgical exams and ethics seems to be the main reasons why blinding is more feasible for Clinical Trials than Surgical ones. As Double-Blinding is extremely difficult to achieve in Surgical Trials, it is almost impossible for them to reach Cochrane’s Platinum level of evidence. In this way, Cochrane Musculoskeletal Group proper grading for primary trials does not seem suitable for surgical trials. Sample Size Calculation is key factor to avoid Type II error but it is present in only 5.22% of primary papers analysed. This is an important reason why SRs lack statistical power and reliability36 and it must be highlighted in congresses and discussions in order to avoid biased conclusions of primary papers. Another important point to be considered in trials is data loss. There is tendency towards a higher drop out rate amongst patients who failed to respond to treatment2 resulting in bias towards positive results6. Intentio-to-Treat (ITT) is a good tool to avoid this type of bias. However in this study, the major part of the entire assessed primary papers that used ITT did not even mention the type of ITT technique used. Using Per-Protocol can estimate effectiveness to be overly optimistic, driving researchers to biased conclusions2. A reliable statistical analysis is also very important for achieving reliability. Different statistical approaches may be necessary in different conditions, depending on sample size, distribution of data and many other factors4. Many primary papers present results without mentioning data distribution verification and insufficient detail about statistical methods used. Only 18.69% of all SRs and 30.70% of primary papers presented analyses of statistical methodology. This must alerts investigators about potentially biased results and misleading conclusions38. Current high standards for Clinical Trials require data entry to be scrutinized for reliability. Strategies include reading aloud18, single data entry with cross check42 and double data entry7. All SRs assessed showed strategies used, but no primary paper reported data entry strategies. In fact, the whole set of primary papers never mentioned it. Good Clinical practices have standardised all legal and ethical steps to be followed in order to conduct a Clinical Trial. However, monitoring is main concern within this standardization17. Monitoring improves reliability by checking all steps within study. Only two primary clinical papers cared about this aspect in our study. A possible solution for improving monitoring could be subspecialty societies or international collaborations to assume this role.
Heterogenity is key factor within a meta-analysis. It shows how different results are among trials. So, the more heterogeneous results are, the more incompatible they will be, reflecting difficulty in assessing outcomes. In this review, 40.54% of SRs presented moderate to low rate of heterogeneity, suggesting better standardization of procedures, interventions, and/or assessments like the ones proposed by the IDEAL-Collaboration34. Randomization is ‘sine qua non’ for Primary Papers to provide data to meta-analysis within a Cochrane SR. But if not well done they can be under risk of bias. Quasi-randomization can be considered as high risk of bias. From all Shoulder-and-Elbow SRs analysed, randomization seemed not to be a concern at first look, as 63.43% of RCTs were considered low risk, but when stratified only 36.07% of surgical trials had adequate randomization against 75.85% on clinical ones. It clearly shows another fragility of Surgical Papers. Allocation Concealment is important to avoid selection bias and protect randomization. Only 29.14% of clinical RCTs and 29.03% of surgical trials presented low risk of bias allocation concealment. These rates are very low and require significant improvement. Balance at Baseline ensures homogeneity of individuals among groups researched. If imbalance is found, all results might be compromised. The baseline of surgical trials was balanced (low risk of bias) in only 24.73%, while for clinical trials more than double (51.43%). Only 58.28% of RCTs were free of co-interventions in Clinical Trials. This measure was not performed for Surgical Trials. This data exposes an alarming situation wherein confounding factors can be present in 41.72% of the papers. Better inclusion/exclusion criteria are necessary in order to foresee and avoid any possible co-interventions. Adherence to treatment is crucial to adequate treatment and it is considered an important source of bias as noncompliant patients are removed from studies. Withdrawal is considered acceptable when inferior to 20% of all enrolled individuals. We found 62.28% of RCTs to present acceptable withdrawn, which suggest biased conclusions once most dropouts are poor results43,6. Intention-to-Treat analysis with a growning curve, baseline data and admitting failure of treatment are helpful strategies to mitigate this issue. Timing of assessment was just measured at the Clinical SRs group. Surgical trials did not present this data. In 73.71% of the assessments there was a low risk of bias, which seems acceptable. Selective Reporting was just measured at the Surgical SRs group. Low risk was found in just 15.05% of RCTs, which can drive investigators to biased results. The main causes of withdrawal found are: deficiency in randomization (183 papers), retrospective studies (154), not specified results (63), incorrect or insufficient enrolment (62) and incorrect intervention (61). Once again, this data point out deficit of high standard prospective papers in the Shoulded-and-Elbow field. In summary, it is clear that Clinical and Surgical Primary Trials within the Shoulder-and-Elbow subspecialty need to improve their methodological quality in order to reach a suitable pattern of quality. Surgical trials tend to present less quality and more inconclusive results than clinical ones41, because of following reasons: (1) learning curve of surgeons33 – minimally invasive techniques and new procedures tend to be technically more demanding, thus having worse initial results; (2) surgical dexterity33,26 – natural variability among surgeons must be addressed at SRs as a potential cause of bias; (3) evolution of devices – rapid evolution of devices may add additional bias when compared to older models; (4) lower budgets for surgical trials; and (5) variability of lesions – surgical trials have to group variable similar lesions in packages in order to harmonize the baseline. Local and international societies of specialties and subspecialties will have to work hard together to get into an agreement about methodologies in their research. The IDEAL-Collaboration34 has been a pioneer on this field, establishing and improving research methodology for future Surgical Trials, but it still lacks recognition and acceptance by societies.
Limitations
This study is based only on SRs presented by Cochrane, which demands very high standards of methodology. Therefore, data presented here may underestimate methodological problem of primary papers.
As data assessed in this paper were extracted from Cochrane’s SRs, not directly from the primary trials, they might be suscectible to errors, misses or faults.
Conclusion
As most Systematic Reviews in Shoulder and Elbow Surgery contain primary trials and RCTs with a high risk of bias, their conclusions must be interpretated with caution. Data from this study may be helpful for future generations of shoulder-and-elbow researchers helping them to focus on methodological quality improvements and thereby enhance worldwide discussion about surgical research methodology, standardized outcomes, timing of assessment and adequate monitoring. Also, it may help to establish new standards for primary surgical trials within shoulder and elbow surgery, like the IDEAL-Collaboration has done in many other surgical fields.
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(Abstract Full Text HTML) (Download PDF)
Proximal Humerus Non Union
/0 Comments/in Vol 1| Issue 1| Oct-Dec 2016 /by ASESADMIN2016Acta of Shoulder and Elbow Surgery | Volume 1 | Issue 1 | Oct-Dec 2016 | Page 8-13| Ashish Babhulkar.
Authors: Ashish Babhulkar [1]
[1] Shoulder & Sports Injury Specialist, Deenanath Mangeshkar Hospital, Pune
Address of Correspondence
Dr. Ashish Babhulkar
Shoulder & Sports Injury Specialist, Deenanath Mangeshkar Hospital, Pune.
Email:- docshoulder@gmail.com
Abstract
Introduction: Non-union proximal Humerus Fractures are complex and the aim of the surgeon should be pain free restoration of function – Functional range of movement & good rotator cuff strength. Pre operative planning in the form of appropriate clinical evaluation, CT scan or other imaging techniques and keeping all options open during surgery is useful. Patients must be counseled about the likely complications since a revision procedure is always fraught with hurdles and obstacles. Careful initial immobilisaiton followed by a supervised structured rehab programme will help the patient achieve a good result. Patients with cartilage damage and OA and in the elderly group may be offered a hemiarthroplasty provided there is no infection and the rotator cuff integrity is maintained. When rotator cuff function is compromised and Surgeon is dealing with a frail elderly patient, a Reverse Shoulder Arthroplasty is probably the surgery of choice , provided Deltoid is unaffected.
Keywords: Proximal humerus fracture, nonunion, fixation.
Introduction
Proximal humerus fractures (PHF) are rather common and in the past have led to significant disabilities. The locked plate concept revolutionized early mobilization of PHF reducing incidence of post fracture stiffness. The provision of angle stable plates even within osteoporotic bones curtailed the use of shoulder replacements for complex PHF. With the success of locked plate fixations, conventional plating became redundant but along with it came high incidence of complications [1,2]. Hemiarthroplasty for PHF was also a revolution for the complex fracture dislocations and non-unions. After about 15 yrs of shoulder hemiarthroplasty we are now understanding its limitations in restoring full function [3]. Non-union after ORIF has been reported between 0% – 25% [3,4,5,6]. The challenges of non union PHF range from soft tissue fibrosis involving the rotator cuff, deltoid and short and long head of biceps, stiffness and capsular contractures, osteopenic bone, shortening and varus and perhaps most important – tuberosity displacements. Naturally, prudence lies in offering joint preservation in younger patients with ORIF and bone grafting if necessary. In the presence of split head fractures, late presentation of PHF, even in younger patients, and in the presence of AVN, it may not be possible to offer a joint preservation option. In the same vein elderly patients with non-union PHF are likely to be treated with shoulder hemiarthroplasty but this need not be the norm. The author classifies the elderly into three groups – (A) Less than 60yrs with adequate bone stock and vascularity in proximal humerus – may be offered a revision fixation with a locked plate and bone grafting. (B) The older than 60 yrs with good shoulder function and a healthy rotator cuff – should be offered a shoulder hemiarthroplasty which eliminates the doubt about union rates in elderly and may reduce the time to rehabilitation. A robust tuberosity fixation technique is however critical. The other group of elderly patients (C) above 70 years, frail, poor or absent rotator cuff function [7], with severe osteopenia have a high rate of complication [8]. The introduction of reverse shoulder arthroplasty (RSA) has changed the outlook for these very elderly patients and provided consistent restoration of function though with its added problems and issues. Absence of signs of union six months after fixation should qualify for a non-union. Lack of bridging or callous across the fracture site at two months could be a sign heralding non-union. Each case is diverse in nature and could fall between the three major groups and should be treated with its individual merit. Absence of infection and neuro-vascular deficit is vital before embarking on any of the above treatment plans.
Anatomy
Proximal humerus has a rich anastomosis of blood supply and hence union is usually brisk and predictable. Four-part fracture dislocations are a reflection of the velocity of trauma and the extent of disruption of the surrounding soft tissue. Thus AVN and non-union rates are often high in four–part fracture dislocations. The ascending branch of circumflex humeral artery is vulnerable near the long head of biceps groove – which is often the water shed line of fracture line between the lesser and greater tuberosity. In order to preserve the vascularity of the fractured head of humerus, the Surgeon should dissect carefully near the biceps groove. Even in the presence of four-part PHF a thick vascular posterior capsule is invariably intact and can serve as a source for restoring vascularity.
Patient factors
Several factors leading to osteoporosis and poor bone quality can be liable for non-union. Tobacco abuse and extreme alcoholics (extent of osteopenia) are common examples. Amongst the medical causes Hypothyroidism and similar metabolic bone disease, drug abuse and nutritional apathy are contributing factors too. Rheumatoid patients on steroids, Cushing’s disease and medication with steroids, anti epileptic medication are known to lead to osetomalacia and osteoporosis. Not all of these factors can be corrected but identification of these factors is important for prognostication. As an example a hypothyroid elderly lady on anti-epileptic medicine may warrant shoulder hemiarthroplasty rather than a plate fixation. Improper varus fixation with gaps between fracture fragments, or non-anatomical fixation will inevitably lead to non-union. Locked plate is a rigid fixation and if applied non-anatomically is a recipe for failure [2]. The intertubercular groove is fault line and fracture line often passes through it. The long head of biceps can easily be trapped between the fragments preventing effective union. Tuberosities are often best fixed with transosseous sutures rather than screws. In such a situation, post op mobilization (especially rotations) should be deferred as tuberosity migration can be a catastrophic failure, especially in Hemiarthroplasty for PHF [8]. PHF in presence of osteoarthritis can lead to troublesome non-union, especially if conserved, as most of the movement will inevitably occur at fracture site. After a conservative immobilization, a premature rehabilitation can disrupt the stability and lead to non-union.
Clinical Evaluation
The clinical picture of non-union PHF is uncharacteristic. Many non-union PHF patients are already mobilized and have commenced their ADLS. Pain is seldom a feature of Non union. Also stiffness and inability to reach extreme ranges is a usual feature even after healed Proximal Humerus Fractures. A meticulous examination is desirable prior to planning any intervention. Often patients with non-union present with wasting of muscles especially Deltoid, Supraspinatus & Infraspinatus. If a previous surgery has been performed by a Delto-Pectoral approach, often the anterior deltoid is disproportionately wasted. This could be a result of injury to the branch of axillary nerve to the anterior deltoid. This wasting is permanent and unlikely to reverse. The anterior deltoid powers forward flexion and is an effective padding for the anterior shoulder. Non-union PHF combined with shoulder stiffness is a formidable challenge to overcome. Deltoid wasting as a result of axillary nerve injury should be picked up clinically as it is futile to offer fixation or hemiarthroplasty. It is not infrequent to have normal axillary nerve sensory function in the presence of a Deltoid motor paralysis. The only surgical option in the presence of axillary neuropathy is a shoulder arthrodesis. A EMG will be useful to disprove a neuropathy. The RSA remains as a reliable salvage surgery after complex failures with damage to rotator cuff. It relies primarily on deltoid integrity for its stability. If the deltoid is dysfunctional a RSA is contra indicated. Non-unions are not unusual (31%) [7] in elderly population and the prevalence of rotator cuff tears in asymptomatic individuals above 70. Hence patients above 70yr with non union should be treated with caution. If there were a co-existing rotator cuff tear a revision plating or hemiarthroplasty would be a counter intuitive. Thus the logic of performing a RSA in most patients above 70yrs age. RSA is preferred in the senior citizen as they may be unable to cope with post op immobilization and the specialist rehab required later. Co-morbid factors such as Parkinson’s, Alzheimer’s, diabetes and imbalance can further compromise results of surgery. Although a RSA is meant for rotator cuff deficient shoulders, when performing a RSA for proximal humerus fractures or non-union, it is mandatory to repair the tuberosities with the same technique described for hemiarthroplasty. The reason for this is dual – a) to enhance soft tissue stability around prosthesis, b) healing of tuberosities will restore rotations and improve over all function of the shoulder [9].
Surgical Planning & Technique
The aim of surgery is to restore anatomy and enhance biology of healing. Careful dissection, minimal disruption of vascularity by minimizing use of cautery and need for bone grafting as a stand by. Since most non-union PHF are complex and revision surgeries, we prefer a pre op CT scan to assess the fracture anatomy, displacements reduction strategies can be simplified to some extent. A 3D reconstruction of CT image is far more preferable and informative than axial CT scans. CT provides limited information about the soft tissue cover, though fatty infiltration of supraspinatus and infraspinatus may be assessed on axial & sagittal sections. A more scientific assessment of rotator cuff integrity and quality can be obtained by MRI or USG. If there are implants in situ a good Musculoskeletal (MSK) sonologist can provide the surgeon better information on rotator cuff status provided there is reasonable passive movement of gleno-humeral joint.
Approach
Patient should be operated in the beach chair position with the Image intensifier mounted behind the patient and the monitor screen in clear view of the surgeon. Aligning the image intensifier to provide “True AP” and Axial images is a prerequisite before taking the incision.
Once the screws in proximal fragment have been inserted a good 360 degree rotation of the arm should allow visualization of the joint surface a “proud” screws can be revised there an then. Only a AP view is never adequate to confirm the anatomical reduction and tip apex distance. As a rule, in revision surgery, almost always use the delto-pectoral approach. This is extensile and familiar to all surgeons. The deltoid split approach10 is favoured by surgeons for primary fixation and may not be a wise choice for revision or PHF non-unions. Scarring from delay and non-union may alter landmarks and perhaps render the neuro-vascular structures vulnerable.
Cephalic vein, first structure under the incision may often be absent or scarred or tethered in the scar tissue. In such a scenario, in order to identify the delto-pectoral interval, the surgeon may use individual direction of fibers of deltoid and pectoralis major to identify the interval. The subscapularis is often adherent to conjoined tendon and Deltoid and during the release it is possible that the axillary nerve is in the neighborhood due to the internal rotation contracture of the subscapularis. Subscapularis release not only enhances the exposure but also facilitates later restoration of external rotation.
The Long head of biceps (LHB) is sometimes scarred down between the fracture fragments and I would not hesitate to perform a tenotomy followed by a tenodesis at the end of surgery. A scarred, immobile biceps can be a pain generator post operatively. The identification of the long head of biceps also helps delineate the exact boundary of lesser tuberosity (LT) and greater tuberosity (GT). Intra operative swabs for culture sensitivity is a norm and the authors preference is t take at least three swabs form different areas of the wound. Swab for microbiology are more relevant when performing a Hemiarthroplasty or a RSA. In our experience the incidence of infections or positive swabs is higher when revising per cutaneous K-wire failures of PHF. The shoulder joint is peculiar for being infected with propionibacterium acnes (and also coagulase-negative staphylococcus). It is recommended that at least 5 swabs from different areas of the wound be incubated for at least 14 days [11]. Presence of infection during a revision may entail a two-stage revision (Fig 5,6,7,8). However, if the infection is not overt and the swab reports turn up positive post operatively, then inadvertently a single stage revision has been performed. The functional results of single stage revision are far superior than two stage revision. There is a trend toward higher infection rates in revision surgery compared with primary arthroplasty groups. As previously mentioned, the large subacromial dead space, the compromised general health of some patients, and the large surgical dissection, especially in revision cases, may predispose to later infection. However, If prior knowledge of infection of operated case of PHF is available then a two stage revision should be planned with a antibiotic loaded cement spacer to maintain soft tissue balance. (Fig. 5,6,7,8). Irrespective of the nature of fracture or operative plan, the surgeon must keep iliac crest prepared for bone grafting (or have access to synthetic bone graft substitutes) and also keep a prosthesis on the back table, just to avoid any embarrassing last minute intra-operative surprises. If there is any free tuberosity fragment, then at this stage each must be held with a mattress Ethibond #2 or a stronger super suture. It may be ideal to use different coloured sutures for ease of suturing later on. Our choice is a locked plate and its standard procedure of fixation including the first screw as non-locking cortical screw and the calcar screw as the most important element of the locked plate. A fibular cortical strut graft may be of help when the bone is osteoporotic, calcar is missing and the surgeon needs a biological augment to prevent head collapse. Sometimes the radiographs reveal a two-part fracture that can be fixed with a plate. Intra-operatively it may reveal an egg shell humeral head that is severely osteoporotic from within. In such cases a preparation for a fibular graft can be helpful (Fig 3 & 4). A vertical strut graft (can be split in two) is to be passed within the canal and screws should capture the fibular graft as they enter the far cortex.
Tuberosity Fixation
Tuberosity repair, retention and eventual healing is most challenging task. Over the years several techniques have emerged to ensure a robust repair and secure healing of tuberosities. Even then factors such as osteoporotic bone, tiny comminuted fragments and bone loss at tuberosity remain beyond the control of the surgeon. Both tuberosities are subject to shear stresses and are often osteoporotic or wafer thin fragments. Our recommendation for ideal stabilisation of tuberosities is to use a super suture or at least ethibond #5. The sequence of suturing is – 1- GT to humerus, 2- LT to humerus, and 3- GT to LT to close the rotator interval. In addition, the critical suture is the cerclage suture described by Frankel [12] for Hemiarthroplasty after proximal humerus fractures.
The cerclage suture adds another axial plane to consolidate the repair and hold it stable. It is necessary that both the tuberosities heal anatomically to restore good function and rotational control. We use the same principle for RSA for complex PHFs in the elderly. We do not recommend steel wires for tuberosity repair. In addition to the above technique, we also recommend the Nice Knot[13] which is a dynamic self-locking knot and has been proven stronger than the conventional surgical knot in another study which is submitted for publication. Due to diverse configuration of various PHF, it is not possible to ensure bone to bone contact after tuberosity repair always. Often, even if some bone contact is achieved, this is marginal and may not be enough for creeping substitution to occur across the fracture line. On the other hand, some humeral prostheses have a smooth metal stem which is most unlikely to allow tuberosities to heal against the smooth stem. Tuberosity union to Hydroxyapatite to trabecular metal stems has been documented. Our recommendation is to use a fracture specific trauma stem (Fig. 11) that has features to encourage tuberosity adherence, integration leading to eventual union. Salient features of a trauma stem are dense hydroxyapatite coating, honeycomb proximal friction fit and smooth niche at medial calcar to allow smooth passage of cerclage sutures. Stem height in the humeral canal cannot be determined as fracture configurations are diverse. Every effort should be made to replicate the stem insertion height (Often may have to be left proud due to bone loss or distal level of PHF). If the stem has identical markings (Fig.11) as the rasp, then the surgeon can precisely identify the exact depth of insertion of the definitive stem. Hemiarthroplasty in fractures is a distinctly different surgery as compared to hemiarthroplasty for non-traumatic conditions. It is more complex than a conventional hemiarthroplasty and the results are less gratifying [14]. Firstly the typical landmarks such as LHB or GT & LT are often missing or displaced and comminuted. Secondly the neck cut has been taken by nature and hence the depth of insertion is variable depending on site of the fracture line. Thirdly the quality of rotator cuff cannot be established pre operatively due to the existing trauma.
Fourthly anatomical version for a given case is impossible to be assessed precisely due to the exploded proximal humerus. As per our cadaveric study of 67 humerii, submitted for publication, maximum variation occurred in humeral version which varied from 20º to 50º (mean 36.85 ±7.72). In addition, often a axillary nerve injury, which is difficult to detect in fresh trauma, may compromise the outcome in few patients. Although most of us prefer an uncemented stem, when the fracture line extends into the metaphysis, it may be necessary to cement the lower half of the stem to provide additional stability.
Complications
By far stiffness and incompetent rotator cuff are the commonest complications after surgery for non-union PHF. Due to complexity of failed treatment of PHF, revision nature of surgery and lengthy surgical exposure, complications after surgery for non-union PHF are likely to be more common than primary treatment of PHF. However the most frequent issue with internal fixation, especially Locked plates, remains proud screws and these may seriously wear out the cartilage of the glenoid leading to a major issue (Fig 13). Due to tedious nature of surgery, scarring of soft tissues and likely bleeding, Injury to axillary and suprascapular nerve could be sinister and lead to a rather poor residual function of the shoulder. Infection though uncommon may be seen due to difficult dissection, post op haematoma and prolonged surgical exposure. AVN of the humeral head is relatively frequent with the overall rate approaching 35% (reported range: 6–75%). The most important predisposing factors are – length of the metaphyseal beak, integrity of the medial hinge, Anatomic neck fracture. When all three features are present then there is a 97% positive predictive value for AVN. Most patients with AVN are likely to improve to a good to excellent result without interference15,16. Hence, it may be prudent to give a significant rehab trial before an arthroplasty is contemplated.
Conclusion
Non-union proximal Humerus Fractures are complex and the aim of the surgeon should be pain free restoration of function – Functional range of movement & good rotator cuff strength. Pre operative planning in the form of appropriate clinical evaluation, CT scan or other imaging techniques and keeping all options open during surgery is useful. Patients must be counseled about the likely complications since a revision procedure is always fraught with hurdles and obstacles. Careful initial immobilisaiton followed by a supervised structured rehab programme will help the patient achieve a good result. Patients with cartilage damage and OA and in the elderly group may be offered a hemiarthroplasty provided there is no infection and the rotator cuff integrity is maintained. When rotator cuff function is compromised and Surgeon is dealing with a frail elderly patient, a Reverse Shoulder Arthroplasty is probably the surgery of choice , provided Deltoid is unaffected.
References
1 Agudelo J, Schurmann M, Stahel P et al. Analysis of efficacy and failure in proximal Humerus fractures treated with locking plates. J Orthop Trauma 2007;21(10):676-681.
2 Owsley KC, Goryca JT. Fracture Displacement and screw cutout after open reduction and locked plate fixation of proximal Humerus Fractures. J Bone Joint Surg Am 2008;90(2):233-240.
3 Bosch U, Skutek M, Fremerey RW, et al (1998) Outcome after primary and secondary hemiarthroplasty in elderly patients with fractures of the proximal humerus. J Shoulder Elbow Surg; 7(5):479–484.
4 Rose PS, Adams CR, Torchia ME, Jacofsky DJ, Hostad E. Displaced proximal Humerus Fractures: results of conservative treatment. Injury 1992;23(1): 41-43.
5 Schulte LM, Matteini LE, Neviaser RJ. Proximal periarticular locking plates in proximal Humerus Fractures: functional outcomes. J Shoulder Elbow Surg 2011:20(8):1234-40.
6 Sudkamp N, Bayer J, Hepp P et al/ Open Reduction & internal reduction of proximal Humerus Fractures with use of the locking proximal humerus plate. Results of a prospective, multicenter, onservational study. J Bone Joint Surg Am 2009;91(6): 1320-1328.
7 Tempelhof S , Rupp S, Seil R. Age related prevalence of rotator cuff tears in asymptomatic shoulders. J Shoulder Elbow Surg. 1999 Jul-Aug;8(4):296-9.
8 Boileu P, Trojani C, Walch G, Krishnan S, Romeo A, Sinnerton R. Shoulder arthroplasty for the treatment of sequelae of fractures of the proximal Humerus . J Shoulder Elbow Surg 2001;10:299-308.
9 Florian Grubhofer, Karl Wieser, Dominik C. Meyer, Sabrina Catanzaro, Silvan Beeler, Ulf Riede, Christian Gerber. Reverse total shoulder arthroplasty for acute head-splitting, 3- and 4-part fractures of the proximal humerus in the elderly J Shoulder Elbow Surg , 2016 Mar-Apr.
10 Lill H, Hepp P, Rose T, et al (2004) [The angle stable locking proximal- humerus-plate (LPHP) for proximal humeral fractures using a small anterior-lateral-deltoid-splitting-approach – technique and first results.] Zentralbl Chir.; 129(1):43–48.
11. Athwal GS, Sperling JW, Rispoli DM, Cofield RH.Acute deep infection after surgical fixation of proximal humeral fractures. J Shoulder Elbow Surg. 2007 Jul-Aug;16(4):408-412.
12. Frankle MA1, Ondrovic LE, Markee BA, Harris ML, Lee WE 3rd. Stability of tuberosity reattachment in proximal humeral hemiarthroplasty. J Shoulder Elbow Surg. 2002 Sep-Oct;11(5):413-20.
13. Hill SW, Chapman CR, Adeeb S, Duke K, Bouiane MJ. Biomechanical evaluation of the Nice Knot. Int J Shoulder Surg. 2016:10;15-20.
14. P. Boileau, S.G. Krishnan, L. Tinsi, G. Walch, J.S. Coste, D. Molé. Tuberosity malposition and migration: Reasons for poor outcomes after hemiarthroplasty for displaced fractures of the proximal humerus.Sep-Oct 2002, Vol 11, Issue 5, 401-412.
15. Hertel R, Hempfig A, Stiehler M, Leung M. Predictors of humeral head ischaemia after intracapsular fractures of the proximal humerus. J Shoulder Elbow Surg. 2004; 13: 427-433.
16. Nho SJ, Brophy RH, Barker JU, Cornell CN, MacGillivray JD. Management of proximal humeral fractures based on current literature. J Bone Joint Surg Am. 2007; 89(Suppl 3): 44-58).
(Abstract Full Text HTML) (Download PDF)
Arthroscopic Fixation of Os Acromiale with Cannulated Screws
/0 Comments/in Vol 1| Issue 1| Oct-Dec 2016 /by ASESADMIN2016Acta of Shoulder and Elbow Surgery | Volume 1 | Issue 1 | Oct-Dec 2016 | Page 44-46 | Jose Carlos Garcia Jr, Mário Henrique Lobão Gonçalves, Márcio Eduardo Kozonara, Luciano Pascarelli, Roberto Bongiovanni.
Authors: Jose Carlos Garcia [1], Mário Henrique Lobão Gonçalves [1], Márcio Eduardo Kozonara [1], Luciano Pascarelli [2], Roberto Bongiovanni [2], Rafael Gadioli [1]
[1] NAEON-Santa Catarina Hospital.
[2] IFOR Hospital.
Address of Correspondence
Dr. Jose Carlos Garcia Jr., MD, MSc, PhD
NÆON-Hospital Santa Catarina-SP-Brazil
Email: jose.cjunior@hsl.org.br
Abstract
Introduction: Os acromiale is a developmental fusion failure of an acromion accessory ossification nucleus. It is associated to higher rates of Impingement Syndrome and rotator cuff tears due to narrowing of subacromial space. Surgical treatment of symptomatic os acromiale is classically done by open incision osteosynthesis or removal of the loose bone fragment. This study presents a modern minimally invasive arthroscopic technique and its preliminary result.
Methods: 13 arthroscopic surgeries were performed on patients with symptomatic os acromiale between 2007 and 2013. Outcomes were evaluated by UCLA scores before and 2 years post-operatively.
Results: Average follow up was 65.23 months (32-105). Pre-operative UCLA averaged 21.46±0.87 rising to 28.92±1.57 at 2 years post-operatively (p=0.001).
Adverse results occured in two patients: one patient had osteolysis of the anterior acromion fragment requiring a switch to open osteosynthesis; and another patient had fragmentation of the acromion during procedure and had to be excised.
Conclusion: Arthroscopic os acromiale osteosynthesis is still a difficult and challenging surgery. Evolution of technique and devices has been encouraging surgeons to make it doable and reproducible. Although there is not significant evidence of long-term benefits of arthroscopic over open technique, it is a minimally invasive procedure with better cosmetic results, reduced postoperative pain and magnified optic access to several shoulder structures.
Key words: Os Acromiale, Shoulder arthroscopy, rotator cuff.
Introduction
Os acromiale is an uncommon shoulder disorder derived from nonunion of acromion accessory ossification centers. It is estimated to occur in 2.7% of shoulders (8). Acromium ossification nuclei rise between 15 to 18 year-old and usually get completely fused by 25 year-old (9). Failure of fusion might ensue at any ossification centers: preacromion, mesoacromion, metacromion or basiacromion. The most common type of os acromiale is the mesoacromiale, followed by preacromiale and metacromiale (12,14). Basiacromiale type is extremely rare. Excessive movement at fusion sites is thought as a possible reason for os acromiale formation (6) since impingement occurs over the anterior part of acromion. Most os acromiales are silent, only being diagnosed after imaging in patients suspected of Impingement Syndrome. Main symptoms are chronic sore shoulder, pain on elevation, night pain and movement restraint. There may be tenderness to palpation over the site of the nonunion. High rates of Impingement Syndrome are associated to os acromiale (11), whose prevalence in patients with massive rotator cuff tears rises up to 12% and it can be as high as 32% among those presenting cuff arthropathy (1). When bilateral involvement is present, prevalence reaches its utmost 62%(7,12,14). Treatment of os acromiale has not been well established yet. Some suggest removal of the acromion loose fragment in symptomatic patients (9), whereas others prefer stable fixation if fragment is big enough (4,16). Osteosynthesis of mesoacromiale and metacromiale seems to have better results than excision by preserving anterior deltoid muscle attachment intact (16). Open osteosynthesis and bone grafts (2) have also been described to fix os acromiale. The development of shoulder arthroscopy allowed surgeons to access many different structures of shoulder, including the acromion. Recently a cadaveric study presented an arthroscopic technique to fix the os acromiale using 2 cannulated screews (5). This study presents results of an all-arthroscopic technique for treating symptomatic os acromiale.
Material and Methods
From 2007 to 2013, 13 patients underwent arthroscopic osteosynthesis for os acromiale. All patients were assessed prospectively according to the IDEAL-Collaboration (10) surgical research methodology.
Inclusion criteria are: over 18 years-old; shoulder pain resilient to conservative treatment for longer than 6 months; diagnosis of mesoacromiale or metacromiale, Liberson classification type 1 (8) on MRI or CT scan; and having more than 2 years of follow-up. Patients without pre-operative assessment and previous shoulder surgeries were excluded. Assessment of patients with UCLA score (13) was done before surgery (baseline) by the senior author and 2 years post-operativelly by others than the senior author who performed the surgical procedures. Roentgenograms of acromion were obtained at 2 and 5 weeks and 2 years after surgery to confirm union of the acromion. Statistical analyses were performed using Prism6® for Mac (GraphPad Software Inc.). All data were tested for normality using statistical tests of D’Agostino and Person, Shapiro-Wilk and Kolmogorov–Smirnov (KS). The Intention-To-Treat (ITT)(15) principle was used whenever possible. Interim sample size was calculated to determine whether this study achieve significance and statistical power as an adaptive design.
A two-tailed test of significance was used for all possible assessments considering p<0.05 statistically significant. Adverse events, complications and causes of withdrawal were reported for all the patients enrolled in the study. Surgical procedures were all performed by the senior author following the standardized technique that follows(Video 1): patient under general anesthesia in ‘beach-chair’ position, a standard posterior portal was settled to glenohumeral joint and subacromial space inspection using a 30º angled arthroscope and 60mmHg pump pressure; through lateral and anterior portals, bursectomy, coracoacromial ligament release, os acromiale site exposure and fibrotic tissues excision were performed using a 4mm shaver and electrocautery until exposure of cancellous bone of both acromion fragments. An osseous shaver is used to expose the marrow bone(Figs 1 and 2) in order to achieve the best osteosynthesis. The scope is inserted in the lateral portal just under the region of the os acromiale is. A spinal needle was inserted in antero-posterior direction just under acromion as reference for screw insert; two 1mm Kirshner wires are inserted through both acromion fragments(Fig3); finally, two 2.7mm cannulated screws are introduced fixing both parts of the acromion under fluoroscopy. A final Roentgenogram is done in order to confirm the osteosynthesis(Fig. 4)
Results
Thirteen arthroscopic osteosynthesis of os acromiale were performed: 11 right shoulders and 2 lefts, 8 men and 5 women. Average follow-up was 65.23 months (32-105). Baseline UCLA scores average of 21.46 ± 0.87 (SD = 3.15; CI 19.56 to 23.37) rised to 28.92 ± 1.57 (SD = 5.65; CI 25.51 to 32.34) post-operatively confirming statistical difference on nonparametric Wilcoxon matched-pairs test (p=0.001). There was none withdrawal on this study since intention-to-treat (ITT) statistical model was used and sample size necessary to achieve the minimal of 4 points difference between baseline and 2-year follow-up UCLA mean scores was achieved on phase one of this trial. One patient that had a pre-operative 50% partial rotator cuff tear evolved to a complete tear and underwent surgical repair with satisfactory functional outcome at a 2-year period after surgery.
Adverse results occurred in two patients (15.38%). One patient had osteolysis of the anterior acromion fragment, evolving with poor UCLA post-operative score (15 points) and requiring an open procedure to remove screws. Another patient had a fracture of the anterior part of acromion during screw fixation and the fragment had to be excised. Despite this patient had a good result, he was graded the same for baseline and post-operative UCLA scores in order to use ITT analysis.
Discussion
A gold standard for surgical treatment of os acromiale has not been established yet. Several osteosynthesis techniques were described with good and satisfactory outcomes. Until now, there are no trials comparing arthroscopic acromion osteosynthesis in human beings. Our review of scientific literature found only one cadaveric study demonstrating feasibility of performing an arthroscopic acromion fixation(5). Acromion fixation using cannulated screws has shown greater healing rates when compared to K-wires and the rate of radiographic healing has been positively correlated to better clinical outcomes(4). In this study we had 92.31% of union (healing) of os acromiale using 2.7mm screws, which confirms the superiority of cannulated screws.
The diameter of screws seems to be very important since some case reports had shown anterior acromion fragment fractures due to screw sizes over 2.7mm. This is of most importance in women whose acromion tends to be smaller and thinner.
Concerning the significant prevalence of right (84.61%) os acromiales over left-sided ones (15.39%) founded on our study, we identified that from the 2 left-sided cases, one patient was left handed, suggesting that the ‘dynamic subacromial space narrowing caused by os acromiale’ theory might be right. Arthroscopic approach to os acromiale allows better fibrotic tissues excision, which seems to favor the biological aspect of bone healing. It also makes possible accessing and repairing the rotator cuff and other shoulder structures through a minimal wound. While, an open technique would require a much larger incision or more than one wound, to access these same structures althogether. Some authors have presented good results when preacromiale is treated with excision of the bone fragment, but this technique seems not to have acceptable outcomes for mesacromiales(16). All patients enrolled in this trial had mesoacromiale or metacromiale, classified by Liberson as type1(8), confirming the trend of good outcomes with meso-metacromiale osteosynthesis.
Limitations:
Due to rarity of os acromiale it was difficulty to find symptomatic patients to enroll in this study. It took us 4 years to get 13 patients that needed surgical treatment for os acromiale. Multicentric trials would be a solution to improve statistical power of similar studies. This is an IDEAL type 2A trial, phase 1, which means it just enable us to conclude about effective of the surgical procedure, not allowing us to assume its superiority over other techniques. A long-term trial comparing arthroscopic versus open fixation of os acromiale with cannulated screws will be necessary to establish a definite conclusion.
Conclusion
Arthroscopic os acromiale osteosynthesis with cannulated screws is still a difficult and challenging technique. Outcomes of this study prove this technique is effective and reproducible for treatment of os acromiale, with benefits of being minimally invasive and allowing concomitant access to rotator cuff and other shoulder structures. Surgical devices advances may be necessary to facilitate this procedure in order to rise its acceptance among shoulder surgeons. Until now there is not significant evidence of long-term difference between open versus arthroscopic os acromiale fixation with cannulated screws. Further data and randomized controlled trials will be necessary to this purpose.
References
1. McCulloch P, Altman DG, Campbel WB, Flum DR, Glasziou P Marshall JC et al. No surgical innovation without evaluation: ID EAL recommendations. Lancet, 2009; 374:1105-1112.
2. Mudge MK, Wood VE and Frykman GK. Rotator cuff tears associated wit os acromiale. J Bone Joint Surg Am, 1984; 66(3):427-429
3. Nicholson G, Goodman DA, Flatow EL, Bigliani LU. The acromion: Morphologic condition and age-related changes. A study of 420 scapulas. J Shoulder Elbow Surg. 1996;5:1–11.
4. Romeo AA, Bach BR, O’Halloran KM. Scoring systems for shoulder conditions. Am J Sports Med 1996;24:472-476.
5. Sammarco VJ. Os acromiale: Frequency, anatomy, and clinical implications. J Bone Joint Surg Am. 2000;82:394–400.
6. Streiner D, Geddes J. Intention to treat analysis in clinical trials when there are missing data. Evid Based Ment Hea lth 2001;4:70-71.
7. Warner JJ, Beim GM, Higgins L. The treatment of symptomatic os acromiale. J Bone Joint Surg Am. 1998;80:1320–6.
8. Atoun E, Narvani A, Sforza G, Young L, Rath E and Levi O. The Prevalence of os Acromiale in patients with massive rotator cuff tears. Int Jof Orth, 2016; 3(2):525-527.
9. Garcia JC et al. Arthroscopic Bristow-Latarjet Procedure. Arthroscopy, 2012; 28(6): e3-e4.
10. Gerber C, Snedeker JG, Baumgartner D and Viehofer AF. Supraspinatus tendon load during abduction is dependent on the size of the critical shoulder angle: A biomechanical a nalysis.
11. Harris JD, Griesser MJ and Jones GL. Systematic review of the surgical treatment of os acromiale. Intl J Shoulder Surg. 2011; 5 (1): 9-16.
12. Kummer FJ, van Gelderen J and Meislin RJ. Two-screw, arthroscopic fixation of os acromiale compared to a similar, open procedure incorporati ng a tension ba nd: a laborato ry study. Shoulder and Elbow, 2011; 3:85-87.
13. Kurtz CA, Humble BJ, Rodosky MW, Sekiya JK. Symptomatic os acromiale. J Am Acad Orthop Surg. 2006;14:12–19.
14. Liberson F. The value and limitation of the oblique view as compared with the ordinary anteroposterior exposure of the shoulder: A report of the use of the oblique view in 1,800 cases. Am J Roentgenol. 1937;37:498–509.
15. Liberson F. Os acromiale a contested anomaly. J. Bone Joint Surg Am, 1937; 19(3): 683-689.
Video of the Surgical Technique
(Abstract Full Text HTML) (Download PDF)
How to improve Surgical Research: the IDEAL approach
/0 Comments/in Vol 1| Issue 1| Oct-Dec 2016 /by ASESADMIN2016Acta of Shoulder and Elbow Surgery | Volume 1 | Issue 1 | Oct-Dec 2016 | Page 4-6 | Jose Carlos Garcia Jr, Allison Hirst, Joshua Feinberg.
Authors: Jose Carlos Garcia Jr [1], Allison Hirst [2], Joshua Feinberg [3].
[1] NÆON-Santa Catarina Hospital-São Paulo-Brazil.
[2] Oxford University-Oxford-UK.
[3] Maiomenides Medical Center-New York-USA.
Address of Correspondence
Dr. Jose Carlos Garcia Jr., MD, MSc, PhD
NÆON-Hospital Santa Catarina-SP-Brazil
Email: jose.cjunior@hsl.org.br
Abstract
Introduction: Here we introduce the IDEAL Framework and Recommendations for evaluating surgical innovation from an idea of a new technique towards a pivotal trial and beyond. We explain the core concepts here and future editions of this periodical will continue the IDEAL theme. IDEAL offers a rational way to explore the effectiveness and safety of new surgical procedures and medical devices in a more robust, transparent and ethical manner than current practice.
This symposium aims to present to the readers a new rational way to design,conduct and report surgical research based on the principles of the IDEAL-Collaboration and others within shoulder and elbow surgery. We examine how to improve research methods across all stages of evaluating innovation.
Keywords: IDEAL Framework and Recommendations, Research, Surgical Innovations.
Introduction
The evaluation process for developing new medicines is a well-established and regulated pathway conducted by clinical researchers globally. Several steps are involved to minimize harms whilst rigorously testing efficacy of the drug as below:
1) Pre-Clinical Studies: Here, a new medication is studied outside the laboratory and in vivo using an animal model.
2) Phase 0 Studies: Also known as microdosage studies, these provide data on any potential harms of a new medication when administered in humans as opposed to animals. In addition to ensuring that a drug is safe, these studies help determine its basic pharmacodynamics and pharmacokinetics (6).
3) Phase 1 Studies: These are devoted to analyze efficacy, pharmacodynamics and pharmacokinetics in non-comparative trials.
4) Phase 2 Studies: Small case controlled trials comparing a drug against a placebo or another medicine with known and standardized outcomes.
5) Phase 3 Studies: Large randomized trials, generally multicentre, comparing a new drug against a placebo or another medicine with known and standardized outcomes (16).
6) Phase 4 Studies: Post marketing retrospective trials. More devoted to long term safety and effectiveness (11).
Historically the same rigorous standardized process has not developed in surgical research due to both a lack of regulatory requirements for surgical techniques but also due to several other specific challenges inherent in the nature of surgery as a complex intervention. These challenges include difficulties in defining a standard surgical intervention due to iterative changes being made by surgeons, the involvement of learning curves, attributes of individual surgeons’ effects on outcomes and a lack of agreed standard outcome measures in surgery. In addition there is often a lack of equipoise with both surgeons and patients expressing preferences in treatment. However it is possible to construct high-quality RCTs in surgery to test new techniques. The IDEAL Collaboration (www.ideal-collaboration.net/) (Figure 1), an international group of surgeons and research methodologists have developed a rational way to move towards developing pivotal surgical RCTs via a systematic system using robust study designs. The word IDEAL present the initials of the stages of surgical development as following:
Idea, Development, Exploration, Assessment and Longterm study (7). Stages are broadly similar to those implemented in the pharmaceutical industry. Idea is analogous to phase 0, Development – phase 1, Exploration – phase 2, Assessment – phase 3 and Long-term-study phase 4. The only phase with no parallel in the original IDEAL is the preclinical phase, however it is comparable with surgical cadaveric studies performed to test the surgical idea before the technique reaches the live patients. The IDEAL Collaboration is currently updating the Framework and will provide further guidance on this pre-clinical stage. This has been in response to publications by researchers using IDEAL 0(10) and it being an important stage for developing medical devices – IDEAL has now developed a separate IDEAL-D (14, 16).Indeed creating a pathway for evaluation designed to address the unique characteristics of surgical procedures rather than simply applying drug clinical trials to the surgical field offers many advantages. Further research and development of IDEAL by using the Framework in practice will lead to more robust and comparable data thus providing reliable answers to the central questions within the field of surgery. Therefore the IDEAL-Collaboration developed stages for surgical development in a similar way to phases of clinical trials but respecting the characteristics that surgical trials need.
How to use IDEAL in your research
The IDEAL Collaboration has endorsed a number of suggestions for specific study designs and reporting standards which are recommended at different stages in the Framework. These suggestions are underpinned by a series of general principles for design and reporting, which are based on the different questions to be addressed and the challenges faced at each stage in the process (5).
Study design and reporting ideas for improving evidence on surgical and interventional therapy innovation are as follows:
The IDEAL Framework, Recommendations and Proposals:
Summary of key features
The IDEAL Collaboration grew out of an earlier initiative known as the Balliol Group who held a series of conferences at Balliol College, Oxford in 2007-2009 with a commitment to improve the quality of research in surgery. Their discussions led to the development of the IDEAL framework for describing the stages of development of surgical and interventional innovations, and a series of recommendations about how methodology and reporting of research at each of these stages could be improved. The group also made a series of proposals about how specific groups (publishers, funders, regulators, and professional organizations) can help to change the environment for this kind of research in a positive manner. The three tables below summarise the key issues described in the Lancet publications reporting the IDEAL Framework, Recommendations and Proposals in 2009 (1,4,8) and subsequently further detailed in 3 articles published in the BMJ in 2013 (2,3,9).
This initial effort of the IDEAL- Collaboration needs to be expanded to many other important points in order to achieve the best surgical designs for surgical trials. It is known that the current status of surgical trials remain something like a babel tower with regard to initiation of a new procedure, performing it in patients and assessing its safety and efficacy. A wide discussion involving the main surgical societies about the organization of these points must be discussed. Within the field of bone and soft tissue lesions for instance, the variability of lesions is an area that requires better standardization of terms. In order to group these conditions accordingly and provide data that can be applied clinically, it may be useful for surgical trials to be designed in such a way that data is collected on those lesions that share the same clinical characteristics.
This would be made possible by studying the most common lesions within one package allowing for variations to be minimized and comparisons to be made more easily. Within shoulder and elbow surgery we can use the example of lesions of the supraspinatus tendon. Lesions of the supraspinatus tendon with retraction Patte(12) type one and two, not compromising the biceps and with 50% or less degeneration (thus three types of degeneration) would most likely result in (2×3=6) the six most common types of lesions. Within the shoulder and elbow surgery community, to agree to group these lesions together, it is necessary to enter into an international agreement to be entitled, for example, the International Standards for Surgical Trials.
Local and international societies of all specialties and subspecialties would need to work together to arrive at this consensus.. While the author’s preferences to certain outcomes and timing to assess must be respected, a minimum of methodological harmonization is a current necessity. To begin this step towards better standardization it is important for this discussion to take place within all the main surgical organizations. Primary trials need to be improved within a rational harmonization and follow the stages that can make surgical trials more reliable and generalizable. Acta for Shoulder and Elbow Surgery is a journal committed to the new patterns from the IDEAL-Collaboration, CONSORT, COMET initiative and others in order to improve the research quality within the orthopedic subspecialty of shoulder and elbow surgery. The practical guides for investigators evaluating new surgical interventions will be better explored in the following volumes of this journal, beginning by the stages 1, 2a and 2b of the IDEAL Framework (13).
Comet-Initiative is Available from: http://www.comet-initiative.org
The CONSORT statement is Available from: http://www.consort-statement.org
Ideal-Collaboration is Available from: http://www.ideal-collaboration.net
References
1-Barkun JS, Aronson JK, Feldman LS, Maddern GJ, Strasberg SM, for the Balliol Collaboration. Evaluation and stages of surgical innovations. Lancet 2009; 374: 1089–96.
2-Cook JA, McCulloch P, Blazeby JM, Beard DJ, Marinac-Dabic D, Sedrakyan A; IDEAL group. IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. BMJ. 2013 Jun 18;346:f2820.
3-Ergina PL, Barkun JS, McCulloch P, Cook JA, Altman DG; IDEAL group. IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages. BMJ. 2013 Jun 18;346:f3011.
4-Ergina PL, Cook JA, Blazeby JM, Boutron I, Clavien PA, Reeves BC, Seiler CM, for the Balliol Collaboration, Challenges in evaluating surgical innovation. Lancet 2009; 374: 1097-104.
5-Hirst A, Agha RA, Rosin D, McCulloch P. How can we improve surgical research and innovation?: the IDEAL framework for action. Int J Surg. 2013;11(10):1038-42.
6-Kummar S, Rubinstein L, Kinders R, Parchment RE, Gutierrez ME, Murgo AJ et al. Phase 0 clinical trials: conceptions and misconceptions. Cancer Journal 2008, 14(3), May-Jun: 133-137.
7-McCulloch, P., Altman, D.G., Campbel, W.B. et al (2009) ‘No surgical innovation without evaluation: IDEAL recommendations.’ Lancet, 374, pp. 1105-1112.
8-McCulloch P, Altman DG, Campbell WB, et al, for the Balliol Collaboration. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009; 374: 1105–12.
9-McCulloch P, Cook JA, Altman DG, Heneghan C, Diener MK; IDEAL group. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ. 2013 Jun 18;346:f3012.
10-Menon M, Abaza R, Sood A, Ahlawat R, Ghani KR, Jeong W, Kher V, Kumar RK, Bhandari M. Robotic Kidney Transplantation with Regional Hypothermia: Evolution of a Novel Procedure Utilizing the IDEAL Guidelines (IDEAL Phase 0 and 1). Eur Urol. 2013 Nov 20. pii: S0302-2838(13)01208-6.
11-National Cancer Institute. Phase IV Trial. Available from: http://www.cancer.gov/dictionary?cdrid=45835 [Accessed 10 August 2016]
12-Patte D. Classification of rotator cuff lesions. Clin Orthop Relat Res. 1990 254:81-86.
13-Pennell CP, Hirst AD, Campbell WB, Sood A, Agha RA, Barkun,JS et al. Practical guide to Idea, Development and Exploration Stages of IDEAL Framework and Recommendations. Br J Surg. 2016 Apr;103(5):607-615.
14-Pennell CP, Hirst A, Sedrakyan A, McCulloch PG. Adapting the IDEAL Framework and Recommendations for medical device evaluation: A modified Delphi survey. Int J Surg. 2016 Apr;28:141-8.
15-Sedrakyan A, Campbell B, Merino JG, Kuntz R, Hirst A, McCulloch P. IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. BMJ. 2016 Jun 9;353:i2372.
16-Temple, R. (2000) Current definitions of phases of investigation and the role of the FDA in the conduct of clinical trials. American Heart Journal, 2000 apr;139(4):133-S135.
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