Tenotomy versus Tenodesis in the treatment of the long head of biceps brachii tendon lesions

BACKGROUND: The superiority of tenotomy vs. tenodesis for surgery on lesions of the long head of the biceps brachii tendon is still under debate. Indeed, high-quality evidence is lacking, mainly because of methodological problems, such as retrospective design, population sample size or lack of patient randomization. METHODS/DESIGN: The study will be a two-center, double-blind, randomized, controlled trial to compare patients treated with biceps tenotomy or tenodesis for lesions of the long head of the biceps brachii tendon over a 2-year follow-up period. The study participants will be 128 adults with biceps brachii tendinopathy and supraspinatus tendon tears. The primary end point will be the postoperative difference in the Constant-Murley score (CMS) between the 2 groups at the two-year follow-up. A comparison of the mean improvement with standard age- and gender-related CMS will be performed. The secondary end point will be evaluation of the postoperative general health of patients, as evaluated with Short Form 36 (SF-36) scores. The number and severity of complications associated with use of the different surgical techniques will be assessed. DISCUSSION: This study will be the first randomized and appropriately powered clinical trial to directly compare tenotomy and biceps tenodesis. The results of this study will help to establish clinical practice guidelines for patients suffering from lesions of the long head of the biceps brachii tendon, providing important information to patients and health care providers about the possible complications, outcome predictors and effectiveness of the targeted interventions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN38839558