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Outcomes of Massive Rotator Cuff Tendon Tear Treatment.

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Sep 2023 to Jan 2024v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06016439
Lead Sponsor Tartu University Hospital
Collaborators: University of Tartu
Conditions
(from sponsor)
Rotator Cuff Tears, Rotator Cuff Syndrome
Related terms Lacerations, Rotator Cuff Injuries, Rupture, Shoulder Injuries
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov