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Primary Arthroscopic Stabilization for a First-Time Anterior Dislocation of the ShoulderA Randomized, Double-Blind Trial
C. Michael Robinson, BMedSci, FRCSEd(Orth)1; Paul J. Jenkins, MBChB, MRCS(Ed)1; Timothy O. White, MD, FRCSEd(Orth)1; Andrew Ker, BSc(Med Sci)1; Elizabeth Will, MSc, MCSP1
1 The Royal Infirmary of Edinburgh, Old Dalkeith Road, Edinburgh EH16 4SU, United Kingdom. E-mail address for C.M. Robinson: c.mike.robinson@ed.ac.uk
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Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.
A commentary is available with the electronic versions of this article, on our web site (www.jbjs.org) and on our quarterly CD-ROM (call our subscription department, at 781-449-9780, to order the CD-ROM).
Investigation performed at The Edinburgh Shoulder Injury Clinic, Royal Infirmary of Edinburgh, Edinburgh, United Kingdom

The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2008 Apr 01;90(4):708-721. doi: 10.2106/JBJS.G.00679
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Abstract

Background: Anterior dislocation of the glenohumeral joint in younger patients is associated with a high risk of recurrence and persistent functional deficits. The aim of this study was to assess the efficacy of a primary arthroscopic Bankart repair, while controlling for the therapeutic effects produced by the arthroscopic intervention and joint lavage.

Methods: In a single-center, double-blind clinical trial, eighty-eight adult patients under thirty-five years of age who had sustained a primary anterior glenohumeral dislocation were randomized to receive either an arthroscopic examination and joint lavage alone or together with an anatomic repair of the Bankart lesion. Assessment of the rate of recurrent instability, functional outcome (with use of three scores), range of movement, patient satisfaction, direct health-service costs, and treatment complications was completed for eighty-four of these patients (forty-two in each group) during the subsequent two years.

Results: In the two years after the primary dislocation, the risk of a further dislocation was reduced by 76% and the risk of all recurrent instability was reduced by 82% in the Bankart repair group compared with the group that had arthroscopy and lavage alone. The functional scores were also better (p < 0.05), the treatment costs were lower (p = 0.012), and patient satisfaction was higher (p < 0.001) after arthroscopic repair. The improved functional outcome appeared to be mediated through the prevention of instability since the functional outcome in patients with stable shoulders was similar, irrespective of the initial treatment allocation. The patients who had a Bankart repair and played contact sports were also more likely to have returned to their sport at two years (relative risk = 3.4, p = 0.007).

Conclusions: Following a first-time anterior dislocation of the shoulder, there is a marked treatment benefit from primary arthroscopic repair of a Bankart lesion, which is distinct from the so-called background therapeutic effect of the arthroscopic examination and lavage of the joint. However, primary repair does not appear to confer a functional benefit to patients with a stable shoulder at two years after the dislocation.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    C. Michael Robinson, BMedSci, FRCSEd(Orth)
    Posted on May 19, 2008
    Dr. Robinson, et al. respond to Dr. Shyamalan, et al.
    Edinburgh Shoulder Clinic, Royal Infirmary of Edinburgh, Edinburgh, UK

    We thank Shyamalan and his colleague for their comments about our study(1), and are grateful for the opportunity to respond.

    The previous studies which examined arthroscopic lavage alone(2-5), as well as the numerous studies which had examined the therapeutic effects of primary arthroscopic Bankart repair in the 1990’s (most notably Kirkley, et al.(6) provided the impetus for the development of this study. These studies showed therapeutic effects from both arthroscopic lavage alone, and arthroscopic Bankart repair, when compared with standard nonoperative treatment(2-5). There was, therefore, a need to compare the therapeutic responses to arthroscopic lavage either alone, or together with Bankart repair. This also provided a unique opportunity for “double-blinding” in the trial design.

    As we described in the discussion section of our paper, arthroscopic lavage does appear to have some therapeutic benefit in reducing recurrent instability, when compared with “historical” control groups. We presume Mr Shyamalan and his colleague are referring to our previous “observational” study of recurrence after primary dislocation(7), and not the review article which they reference in their bibliography. Such comparisons between different studies are notoriously unreliable and should be approached cautiously. These comments also apply to their discussion of the relative merits of external rotation bracing. We are unable to detect the section in our paper where we discussed “….a lavage group in external rotation brace post-operatively…..”, and we are uncertain as to their meaning here.

    The criteria for recruitment into our study are among the most inclusive of all studies assessing shoulder instability. As demonstrated in our previous study(7), and in a recent landmark paper(8), post-dislocation instability diminishes with increasing age. Although it may seem initially appealing to include older patients in therapeutic studies of instability, their results may reduce the power of the study as a whole to demonstrate therapeutic benefits. The foundations of scientific inquiry and evidence-based medicine require rigorous testing of hypotheses. Opinion and “common-sense”, although both reputedly prevalent among orthopaedic surgeons, are rated low in the “Level of Evidence” ladder, in comparison with the results of randomized double-blind controlled trials. Nevertheless, we agree with Mr Shyamalan and his colleague that the results of our study support the use of arthroscopic Bankart repair in selected younger first-time dislocators, who have been adequately counseled about the “risk-benefit” of the surgery. As described in the discussion section of our paper, this is now our current practice.

    References:

    1. Robinson CM, Jenkins PJ, White TO, Ker A, Will E. Primary arthroscopic stabilization for a first-time anterior dislocation of the shoulder. A randomized, double-blind trial. Journal of Bone & Joint Surgery Am. 2008;90(4):708-721.

    2. Wintzell G, Haglund-Akerlind Y, Ekelund A, Sandstrom B, Hovelius L, Larsson S. Arthroscopic lavage reduced the recurrence rate following primary anterior shoulder dislocation. A randomised multicentre study with 1-year follow-up. Knee surgery, sports traumatology, arthroscopy. Official journal of the ESSKA. 1999;7(3):192-196.

    3. Wintzell G, Haglund-Akerlind Y, Nowak J, Larsson S. Arthroscopic lavage compared with nonoperative treatment for traumatic primary anterior shoulder dislocation: a 2-year follow-up of a prospective randomized study. Journal of Shoulder and Elbow Surgery/American Shoulder and Elbow Surgeons ...[et al.]. Sep-Oct 1999;8(5):399-402.

    4. Wintzell G, Haglund-Akerlind Y, Tidermark J, Wredmark T, Eriksson E. A prospective controlled randomized study of arthroscopic lavage in acute primary anterior dislocation of the shoulder: one-year follow-up. Knee Surg Sports Traumatol Arthrosc. 1996;4(1):43-47.

    5. Wintzell G, Hovelius L, Wikblad L, Saebo M, Larsson S. Arthroscopic lavage speeds reduction in effusion in the glenohumeral joint after primary anterior shoulder dislocation: a controlled randomized ultrasound study. Knee Surgery, Sports Traumatology, Arthroscopy. Official journal of the ESSKA. 2000;8(1):56-60.

    6. Kirkley A, Griffin S, Richards C, Miniaci A, Mohtadi N. Prospective randomized clinical trial comparing the effectiveness of immediate arthroscopic stabilization versus immobilization and rehabilitation in first traumatic anterior dislocations of the shoulder. Arthroscopy. 1999 Jul-Aug;15(5):507-14.

    7. Robinson CM, Howes J, Murdoch H, Will E, Graham C. Functional outcome and risk of recurrent instability after primary traumatic anterior shoulder dislocation in young patients. J Bone Joint Surg Am. 2006 Nov;88(11):2326-36.

    8. Hovelius L, Olofsson A, Sandström B, Augustini BG, Krantz L, Fredin H, Tillander B, Skoglund U, Salomonsson B, Nowak J, Sennerby U. Nonoperative treatment of primary anterior shoulder dislocation in patients forty years of age and younger. A prospective twenty-five-year follow-up. J Bone Joint Surg Am. 2008 May;90(5):945-52.

    C Michael Robinson, FRCS, Ed(Orth)
    Posted on April 18, 2008
    Drs. Robinson and Jenkins respond to Drs. Patel and Leith
    Edinburgh Shoulder Injury Clinic

    We thank Drs. Patel and Leith for their comments on our study, and are grateful for the opportunity to respond. They rightly point out that operative shoulder reconstruction for recurrent instability is a different entity from that of treatment for a first-time dislocation. Recurrent dislocations are more likely to be associated with secondary osseous lesions (large Hill-Sachs lesions and anteroinferior bony glenoid rim defects), which have recently been shown to deleteriously affect the outcome from arthroscopic repair (1,2). The primary aim of our study was to determine the rate of instability following arthroscopic stabilization or lavage in the acute setting.

    All patients were operated on within 14 days, and the mean times to surgery in the Bankart repair and lavage groups were 7.6 days and 7.9 days respectively. The operative procedures were able to be performed so early in our study, due to a special arrangement which exists in our Unit, whereby all acute dislocations are referred directly to a specialist clinic and there is early access to acute operating theatre time. We would accept that it is unusual to have such early access to operating room time.

    We are uncertain as to whether delaying the acute arthroscopic reconstruction would have an adverse effect on outcome, as this was not examined in out study. However, we feel that it is most logical to perform the reconstruction as soon as possible after the primary dislocation, since we rest the arm in a sling for four weeks after the surgery. Performing the surgery as a delayed “elective” procedure, some weeks after the primary dislocation, would subject the patient to a further period of enforced inactivity, and might further delay their rehabilitation and return to normal activities.

    We agree with Drs. Patel and Leith that further prospective studies are required to investigate the optimal timing and form of treatment for shoulder instability. However, it is necessary to bear in mind that there are important differences between performing the procedure as a prophylactic measure after a first-time dislocation, and as a therapeutic measure in a patient with recurrent instability. This may lead to some complex methodological problems in the design of such studies in the future.

    References:

    1) Burkhart SS, De Beer JF. Traumatic Glenohumeral Bone Defects and Their Relationship to Failure of Arthroscopic Bankart Repairs: Significance of the Inverted-Pear Glenoid and the Humeral Engaging Hill- Sachs Lesion. Arthrosocopy 2000;16:677-694.

    2) Lenters TR, Franta AK, Wolf FM, Leopold SS, Matsen FA 3rd. Arthroscopic compared with open repairs for recurrent anterior shoulder instability. A systematic review and meta-analysis of the literature. J Bone Joint Surg Am. 2007 Feb;89(2):244-54.

    Rahul V Patel, FRCS
    Posted on April 07, 2008
    Treatment of First -Time Anterior Dislocation of the Shoulder
    University of British Columbia, CANADA

    To The Editor:

    We read with great interest the article entitled "Primary Arthroscopic Stabilization For First Time Anterior Dislocation Of The Shoulder, A Randomized, Double-Blind Trial"(1). We would like to congratulate the authors on a very thorough, well designed and conducted study.

    We, at our institution, have long held the same belief, that if surgery is considered by this specialised group of patients, Bankart repair for first time dislocation results in greater patient satisfaction and a reduction in risk of recurrent instability than other surgical treatments. We are also encouraged by your report of greater cost- effectiveness in the longer term.

    If one is to consider arthroscopic lavage for treatment of this group of patients, then clearly the benefit lies in performing this procedure as soon after the dislocation as is safe and possible. In the article you state, "it seems unlikely that performing arthroscopic stabilization as a primary intervention has a clear advantage over the use of this technique as a delayed procedure for patients with recurrent instability after the primary dislocation"(2). With regard to time to surgery therefore, we would be interested to know the mean time to surgery for both groups of patients in the study. In our practice, although consultation may occur 2-4 weeks following the dislocation, even if surgery is planned and agreed on, waiting lists and operating room time availability may delay treatment to a point where in the least, lavage is futile.

    In reality, most surgeons perform arthroscopic Bankart repair as an elective procedure. The interval between consultation and surgery can result in further episodes of instability or dislocation, perhaps causing further intra-articular damage and jeopoardising the success of the planned procedure. Do the authors consider that time to surgery really has no bearing on outcome or would they concede that performing a Bankart repair any time prior to a second time recurrent dislocation improves outcome?

    We believe this question highlights the need for a further prospective study comparing the outcome of arthroscopic Bankart repair performed for patients who have only dislocated once versus the outcome for patients who have dislocated multiple times.

    The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

    References:

    1. Robinson CM, Jenkins PJ, White TO, Ker A. Will E. Primary arthroscopic stabilization for a first-time anterior dislocation of the shoulder. A randomized, double-blind trial. J Bone Joint Surg Am. 2008;90:708-721.

    2. Robinson CM, Jenkins PJ, White TO, Ker A. Will E. Primary arthroscopic stabilization for a first-time anterior dislocation of the shoulder. A randomized, double-blind trial. J Bone Joint Surg Am. 2008;90:719.

    Gunaratnam Shyamalan
    Posted on April 05, 2008
    If it's broken, fix it.
    St. Georges Hospital, UK

    To The Editor:

    We compliment the authors of "Primary Arthroscopic Stabilization for a First -Time Anterior Dislocation of the Shoulder. A Randomized, Double-Blind Trial(1) for a well planned study.

    Primary anterior dislocations of the shoulder are associated with a high risk of instability in young adults(2). We presume that the initial impetus for this study(1) came from Wintzell, et al.(3,4) who proposed that arthroscopic lavage alone conferred an improved outcome, compared to conservative management. Their one year results had a n=60, 30 in each group, showing a 13% re-dislocation rate in the lavage group as opposed to a 43% re-dislocation rate in the conservatively treated group(3). Interestingly, their two year results with an n=30, reported a 20% dislocation rate in the lavage group, but they seem to have lost half the patients(4). The present study(1) reports that lavage alone was associated with a 38% dislocation rate at two years.

    Even though the authors of the current study did not study a non-operatively treated group, their previous study(5) showed a 68% dislocation rate at five years in conservatively managed first time dislocators. This is almost twice the percentage of the lavage group.

    The lavage group was managed with a sling, with the shoulder in internal rotation. Itoi, et al.(6) have quoted a 26% redislocation in an external rotation brace at a minimum of 4 years, even with a less than perfect compliance. We agree with the authors that no one has compared a lavage group in an external rotation brace post operatively.

    We accept the point that trials previous to this for primary stabilisation may have included a narrow group of patients, such as the West Point experience(7), but the authors own numbers show an average age of 25 with 65 patients playing sport, 30 professionally(1).

    In essence, this paper (1) adds weight to the growing evidence that primary stabilisation should be offered to the young, male, first time dislocator. Common sense says performing an arthroscopy but not stabilising the patient has to be missing a golden opportunity to fix the problem.

    The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

    References:

    1. Robinson M, Jenkins PJ, White TO, Ker A, Will E. Primary Arthroscopic stabilzation for a First-Time Anterior Disclocation of the Shoulder. A Randomized, Double-Blind Trial. J Bone Joint Surg Am. 2008;90:708-21.

    2. McLaughlin HL, Cavallaro WU. Primary anterior dislocation of the shoulder. Am J Surg. 1950;80:615 21.

    3. Wintzell G, Haglund-Akerling Y, Ekelund A, Sandstron B, Hovelius L, Larsson S. Arthroscopic lavage reduced the recurrence rate following primary anterior shoulder disclocation. A randomised multicentre study with 1-year follow-up. Knee Surg Sports Traumatol Arthrosc. 1999;7:192-6.

    4. Wintzell G, Haglund-Akerlind Y, Nowak J, Larsson S. Arthroscopic lavage compared with non-operative treatment for traumatic primary anterior shoulder dislocation: a 2-year follow-up of a prospective randomized study. J Shoulder Elbow Srug. 1999;8:399-402.

    5.Robinson CM, Dobson RJ. Anterior Instability of the shoulder after trauma. J Bone Joint Surg Br. 2004;86:469-79.

    6. Itoi E, Hatakeyama Y, Sato T, Kido T, Minagawa H, Yamamoto N, Wakabayashi I, Nozaka K. Immobilization in external rotation after shoulder dislocation reduces the risk or recurrence. A randomized controlled trial. J Bone Joint Surg Am. 2007;89:2124-32.

    7. DeBeradino TM, Arciero RA, Taylor DC. Arthroscopic stabilization of acute initial anterior shoulder dislocation: the West Point experience. J South Orthop Assoc. 1996;5:263-71.

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