Rotator cuff tear is the leading cause of shoulder pain in the elderly. There isn't enough evidence nor clinical guidelines to guide the treatment of massive rotator cuff tears, specially irreparable tears. Arthroscopic partial repair has been widely used and superior capsular reconstruction (SCR), either with allograft, autograft or augmentation with long head biceps brachii tendon (LHBBT), has been recently added. It is showing promising results, but lacking high quality evidence. This is a prospective clinical study to compare the outcomes of different surgical methods for massive rotator cuff tendon tears. Minimal follow-up time will be two years. In this trial, massive rotator cuff tears will be anatomically repaired if possible. For irreparable tears a method will be randomly assigned intra-operatively once a tear is determined to be irreparable - either partial repair or partial repair with superior capsular reconstruction using the long head biceps brachii (LHBB) tendon. Patients who are eligible for the study but refuse operative treatment, will serve as conservative study group. The hypothesis is that massive rotator cuff tears that are reparable will have the best functional outcomes. For irreparable tears, augmentation with LHBBT will give superior results over partial repair.
Age range
50 Years – 80 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change in shoulder strength
Timeframe: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Change in shoulder range of motion.
Timeframe: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Functional outcome according to the American Shoulder and Elbow Surgeons (ASES) score.
Timeframe: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Functional outcome according to the Constant-Murley score (CMS).
Timeframe: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Functional outcome according to the Disabilities of the Arm, Shoulder and Hand (DASH).
Timeframe: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit
Change in pain score
Timeframe: Pre-operative baseline, 6-months, 12-months and 24-months follow-up visit