Long Head of Biceps Tenotomy Is Not Inferior to Suprapectoral Tenodesis in Arthroscopic Repair of Nontraumatic Rotator Cuff Tears: A Multicenter, Non-inferiority, Randomized, Controlled Clinical Trial.

ABSTRACT Purpose The purpose of this study is to determine if long head biceps (LHB) tenotomy is not inferior to suprapectoral LHB tenodesis when performed in conjunction with arthroscopic repair of small to medium sized non-traumatic rotator cuff tears Methods This multicenter randomized non-inferiority trial recruited 100 participants older than 50 years had a supraspinatus / infraspinatus tear sagittally smaller than 3 cm, and arthroscopically confirmed LHB pathology. During arthroscopic rotator cuff repair, 48 patients were randomized to undergo suprapectoral LHB tenodesis and 52 patients to LHB tenotomy. Data were collected pre-operatively, 6 weeks, 3 months and 1 year post operatively. Primary outcome was non-inferiority of the Constant Murley score (CMS) at 1 year follow up. Secondary outcomes included the Dutch Oxford Shoulder Test (DOSS), Disabilities of the Arm Shoulder and Hand questionnaire (DASH), Popeye deformity, elbow flexion strength index (ESI), arm cramping pain and quality of life (EQ5D). Integrity of the rotator cuff repair was assessed with MRI. Differences between intervention groups were analyzed by mixed modeling. Results Mean CMS scores in LHB tenotomy group improved from 44 (95%CI: 39-48) to 73 (95%CI: 68-79). Patients with LHB tenodesis improved from 42 (95%CI: 37-48) to 78 (95%CI: 74-82). The difference between groups at 1 year follow up was 4.8 (97.5%CI: -∞-11.4), p-value for non-inferiority of 0.06. Secondary outcomes also improved over time, with no remarkable differences between groups. Popeye deformity occurred in 33% of tenodesis and 47% of tenotomy patients (p=0.17). Tenotomy was performed with a shorter operative time 73 vs 82 minutes (p=0.03). MRI showed a recurrent rotator cuff tear in 20% of all cases. Conclusion Although statistically ‘inconclusive’ with regard to non-inferiority of CMS at one year follow up, any observed differences between patients with LHB tenotomy compared with LHB tenodesis in all outcome scores were small.