BackgroundLabral 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.MethodsA 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.ResultsThere 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.ConclusionNeither labral repair nor biceps tenodesis had any significant clinical benefit over sham surgery for patients with SLAP II lesions in the population studied.Trial registration numberClinicalTrials.gov identifier: NCT00586742
BackgroundHaving an estimate of the measurement error of self-report questionnaires is important both for assessing follow-up results after treatment and when planning intervention studies. Specific questionnaires have been evaluated for patients with shoulder instability, but not in particular for patients with SLAP (superior labral anterior posterior) lesions or recurrent dislocations. The aim of this study was to evaluate the agreement, reliability, and validity of two commonly questionnaires developed for patients with shoulder instability and a generic questionnaire in patients with SLAP lesions or recurrent anterior shoulder dislocations.MethodsSeventy-one patients were included, 33 had recurrent anterior dislocations and 38 had a SLAP lesion. The patients filled in the questionnaires twice at the same time of the day (± 2 hours) with a one week interval between administrations. We tested the Oxford Instability Shoulder Score (OISS) (range 12 to 60), the Western Ontario Shoulder Instability Index (WOSI) (0 to 2100), and the EuroQol: EQ-5D (−0.5 to 1.0) and EQ-VAS (0 to 100). Hypotheses were defined to test validity.ResultsICC ranged from 0.89 (95% CI 0.83 to 0.93) to 0.92 (0.87 to 0.95) for OISS, WOSI, and EQ-VAS and was 0.66 (0.50 to 0.77) for EQ-5D. The limits of agreement for the scores were: -7.8 to 8.4 for OISS; -339.9 to 344.8 for WOSI; -0.4 to 0.4 for EQ-5D; and −17.2 and 16.2 for EQ-VAS. All questionnaires reflect the construct that was measured. The correlation between WOSI and OISS was 0.73 and ranged from 0.49 to 0.54 between the shoulder questionnaires and the generic questionnaires. The divergent validity was acceptable, convergent validity failed, and known group validity was acceptable only for OISS.ConclusionMeasurement errors and limitations in validity should be considered when change scores of OISS and WOSI are interpreted in patients with SLAP lesions or recurrent shoulder dislocations. EQ-5D is not recommended as a single outcome.
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