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Biceps Tendon- Superior Capsule Reconstruction and Acellular Dermal Matrix Augmentation for Large to Massive Incompletely Repairable Rotator Cuff Tears

Study acronym: SCR-ADM repair
StatusRecruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
Large-to-Massive rotator cuff tears of the shoulder with poor tendon and muscle quality often cannot be fully repaired back to its footprint, and they have a high risk of re-tear. This study evaluates a combined technique for these tears. During surgery, the torn rotator cuff is repaired as far as possible, the long head of the biceps tendon is transposed (rerouted) and fixed to the top of the humeral head, and the repair is augmented with an acellular dermal matrix graft (MegaDerm Plus, L\&C Bio, Republic of Korea). All participants receive the same operation and the same structured rehabilitation program; there is no comparison group. Forty adults aged 40 to 75 years treated at Tam Anh General Hospital, Ho Chi Minh City, Vietnam, will be followed for at least 12 months after surgery. The main outcome is the rate of tendon retear on MRI at 12 months. Pain, shoulder function scores (Constant, ASES, UCLA), range of motion, muscle strength, X-ray findings and complications, including graft-related complications, will also be recorded.
Trial Details
NCT Number NCT07875556
Lead Sponsor Tam Anh Research Institute
Collaborators: Hue University of Medicine and Pharmacy
Conditions
(from sponsor)
Rotator Cuff Tears, Rotator Cuff Injuries, Massive Rotator Cuff Tear
Related terms Rotator Cuff Injuries
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov