Efficacy of labral repair, biceps tenodesis, and diagnostic arthroscopy for SLAP Lesions of the shoulder: a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Surgery 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.</p> <p>Methods/Design</p> <p>A 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.</p> <p>Discussion</p> <p>The results of this trial will be of international importance and the results will be translatable into clinical practice.</p> <p>Trial Registration</p> <p><b>[ClinicalTrials.gov NCT00586742]</b></p

Treatment of Type II SLAP lesions of the shoulder

Background: Discussion of the clinical importance and treatment of type II SLAP lesions has a history spanning more than 25 years. Retrospective, level IV studies showed promising results, but there was a definite lack of high-level evidence. Aims: Our first aim was to evaluate the results after isolated type II SLAP repair. As 10% of these patients presented with a paralabral cyst, our second aim was to assess whether the cyst would resolve after isolated labral repair. Our third aim was to evaluate in a high-level study, the efficacy of labral repair, biceps tenodesis and placebo surgery. Material and methods: In our first study, 107 patients with an isolated SLAP II lesion treated with labral repair were followed for 5 years. Based on the results and discussion of this study, we designed and conducted a randomized controlled trial. Three groups were compared and followed for 2 years; 40 patients in the labral repair group, 39 patients in the tenodesis group and 39 in the sham group. Two cohorts of patients with a SLAP tear and a symptomatic spinoglenoid cyst were also followed. The first study included 42 patients and the second included 47 patients, and all had magnetic resonance imaging postoperatively. Results and conclusion: The results of the prospective cohort study suggested good long-term results after SLAP repair. The two cohorts on labral repair in patients with a SLAP lesion and a concomitant symptomatic cyst suggests that labral repair leads to cyst resolution and significant pain relief. Labral repair, biceps tenodesis and sham-surgery for patients with type II SLAP lesions all yield significant improvement both objectively and subjectively. However, surprisingly, there were no significant differences between the groups in the population studied. The sample was not large enough to perform sub-group analysis, but the fact that surgical treatment was no better than sham treatment, leads us to question the role of operative treatment in this patient group

Sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial

Background: Labral repair and biceps tenodesis are routine operations for superior labrum anterior posterior (SLAP) lesion of the shoulder, but evidence of their efficacy is lacking. We evaluated the effect of labral repair, biceps tenodesis and sham surgery on SLAP lesions. Methods: A double-blind, sham-controlled trial was conducted with 118 surgical candidates (mean age 40 years), with patient history, clinical symptoms and MRI arthrography indicating an isolated type II SLAP lesion. Patients were randomly assigned to either labral repair (n=40), biceps tenodesis (n=39) or sham surgery (n=39) if arthroscopy revealed an isolated SLAP II lesion. Primary outcomes at 6 and 24 months were clinical Rowe score ranging from 0 to 100 (best possible) and Western Ontario Shoulder Instability Index (WOSI) ranging from 0 (best possible) to 2100. Secondary outcomes were Oxford Instability Shoulder Score, change in main symptoms, EuroQol (EQ-5D and EQ-VAS), patient satisfaction and complications. Results: There were no significant between-group differences at any follow-up in any outcome. Between-group differences in Rowe scores at 2 years were: biceps tenodesis versus labral repair: 1.0 (95% CI −5.4 to 7.4), p=0.76; biceps tenodesis versus sham surgery: 1.6 (95% CI −5.0 to 8.1), p=0.64; and labral repair versus sham surgery: 0.6 (95% CI −5.9 to 7.0), p=0.86. Similar results—no differences between groups—were found for WOSI scores. Postoperative stiffness occurred in five patients after labral repair and in four patients after tenodesis. Conclusion: Neither labral repair nor biceps tenodesis had any significant clinical benefit over sham surgery for patients with SLAP II lesions in the population studied

Sick leave and return to work after surgery for type II SLAP lesions of the shoulder: a secondary analysis of a randomized sham-controlled study.

Objectives To compare days on sick leave and assess predictors of return to work following shoulder surgery. Design A secondary analysis of a randomised controlled trial. Setting Orthopaedic department. Participants 114 patients with type II superior labral tear from anterior to posterior of the shoulder. Interventions Labral repair, biceps tenodesis or sham surgery. Outcome measures Sick leave was obtained from national registers for the last year before and 2 years following surgery. Total and shoulder related number of days on sick leave were obtained, using international diagnostic codes. We applied the difference-in-difference approach to compare the differences in the change in mean work days on sick leave between groups over time, backwards logistic regression and lasso regression to evaluate predictors. Results Mean total number of work days on sick leave during the 2 years after surgery was 148 (range 0–460) days. More than 80% of the sick leave days were taken by 22% of the patients. Days on sick leave classified as shoulder-related constituted 80% of the total. In all three treatment groups, the mean total number of days on sick leave doubled the year after surgery. Sham surgery and labral repair had fewer postoperative sickness absence days compared with biceps tenodesis but differences were not significant when adjusted for days of sick leave the year before surgery. Predictors of return to work at 2 years analysed by logistic regression were no sick leave (OR 8.0, 95% CI 2.4 to 26.0) and moderate symptoms of anxiety or depression (OR 0.16, 95% CI 0.05 to 0.5) at inclusion. Similar results were obtained by lasso regression but manual work was an additional predictor. Conclusions Change in mean work days on sick leave comparing sham surgery, labral repair and biceps tenodesis, was not significantly different. Sick leave, symptoms of anxiety and depression, and manual work at inclusion predicted work status 2 years after surgery