Outcomes of Massive Rotator Cuff Tendon Tear Treatment.

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.

NCT Number	NCT06016439
Lead Sponsor	Tartu University Hospital Collaborators: University of Tartu
Conditions	Rotator Cuff Tears, Rotator Cuff Syndrome
Enrollment	80 participants
Start Date	2024-01
Primary Completion	2033-12 (estimated)
Study Completion	2033-12 (estimated)
Updated on ClinicalTrials.gov	2023-11-24