SHAM
Sham surgery versus labral repair or biceps tenodesis for type II SLAP lesions of the shoulder: a three-armed randomised clinical trial
Project owner:
Lovisenberg Diaconal Hospital ( Sigbjørn Dimmen, MD, PhD, Orthopaedic Surgeon)
Summary
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.
Project period
2008 - 2021
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.
doi: 10.1136/bjsports-2016-097098