Abstract
BackgroundSurgery for type II SLAP (superior labral anterior posterior) lesions of the shoulder is a promising but unproven treatment. The procedures include labral repair or biceps tenodesis. Retrospective cohort studies have suggested that the benefits of tenodesis include pain relief and improved function, and higher patient satisfaction, which was reported in a prospective non-randomised study. There have been no completed randomised controlled trials of surgery for type II SLAP lesions. The aims of this participant and observer blinded randomised placebo-controlled trial are to compare the short-term (6 months) and long-term (2 years) efficacy of labral repair, biceps tenodesis, and placebo (diagnostic arthroscopy) for alleviating pain and improving function for type II SLAP lesions.Methods/DesignA double-blind randomised controlled trial are performed using 120 patients, aged 18 to 60 years, with a history for type II SLAP lesions and clinical signs suggesting type II SLAP lesion, which were documented by MR arthrography and arthroscopy. Exclusion criteria include patients who have previously undergone operations for SLAP lesions or recurrent shoulder dislocations, and ruptures of the rotator cuff or biceps tendon. Outcomes will be assessed at baseline, three, six, 12, and 24 months. Primary outcome measures will be the clinical Rowe Score (1988-version) and the Western Ontario Instability Index (WOSI) at six and 24 months. Secondary outcome measures will include the Shoulder Instability Questionnaire (SIQ), the generic EuroQol (EQ-5 D and EQ-VAS), return to work and previous sports activity, complications, and the number of reoperations.DiscussionThe results of this trial will be of international importance and the results will be translatable into clinical practice.Trial Registration[ClinicalTrials.gov NCT00586742]
Highlights
Surgery for type II SLAP lesions of the shoulder is a promising but unproven treatment
Because it is related to the intraarticular insertion of the long head of the biceps tendon, injuries are common in throwing athletes. These lesions are often associated with other shoulder injuries such as rotator cuff tears, glenohumeral instability or impingement, but they may be due to an isolated injury
The Shoulder Instability Questionnaire (SIQ) is a disease-specific health related quality of life instrument validated for use in patients with shoulder instability21]
Summary
The glenoid labrum contributes to stability by increasing joint concavity and dept of the glenohumeral joint socket. A return to their previous level of sports activity varied from 20 to 94% Despite these unpredictable results and a lack of evidence from properly designed studies, shoulder surgeons worldwide perform type II SLAP repairs. Aims There are two aims of this randomised placebocontrolled trial: 1) Compare the short-term (6 months) efficacy of labral repair, biceps tenodesis, and placebo (diagnostic arthroscopy), for alleviating pain and improving function for type II SLAP lesions. Exclusion criteria include previous surgery for SLAP lesions, SLAP lesions with concomitant labral cysts16,], previous surgery for recurrent shoulder dislocation or SLAP lesions, clinical and radiological signs of arthritis of the acromioclavicular15,] or the glenohumeral joints, ruptures of the rotator cuff or biceps tendon11], synovial chondromatosis, fibromyalgia, major somatic or psychiatric disease, and patients that are not able to understand Norwegian or unwilling to accept one of the treatment alternatives
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