Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07875556

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

Sponsor: Tam Anh Research Institute

View on ClinicalTrials.gov

Summary

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.

Official title: Evaluation of Outcomes of Large-to-Massive Incompletely Repairable Rotator Cuff Repair Using Long Head of the Biceps Tendon Transposition and Acellular Dermal Matrix Augmentation

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-09-16

Completion Date

2030-09-30

Last Updated

2026-10-15

Healthy Volunteers

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Massive Rotator Cuff Tear

Interventions

PROCEDURE

Biceps Tendon Transposition + ADM Augmentation

Arthroscopic partial repair of the posterosuperior rotator cuff combined with transposition of the long head of the biceps tendon to the superior greater tuberosity (anchor fixation) and augmentation with an acellular dermal matrix graft (MegaDerm Plus, L\&C Bio, Republic of Korea; 2 mm thick, sized intraoperatively) fixed over the repair in a suture-bridge configuration. Followed by a standardized phased rehabilitation program. Interventions: Procedure - arthroscopic rotator cuff repair with LHBT transposition; Device - acellular dermal matrix graft (MegaDerm Plus).

Inclusion Criteria: * Preoperative: * Age 40 to 75 years * Large posterosuperior rotator cuff tear (supraspinatus and/or infraspinatus) confirmed clinically and on MRI * Tear size greater than 3 cm on preoperative MRI * At least one risk factor for retear: severe muscle atrophy (occupation ratio \< 40%) or positive tangent sign; supraspinatus fatty infiltration Goutallier grade III or higher, or infraspinatus Goutallier grade II-III; or Rotator Cuff Healing Index (RoHI) \< 7 * Tendon retraction Patte stage II or higher on MRI * No MRI evidence of complete rupture of the long head of the biceps tendon * Written informed consent * Intraoperative (all required for inclusion in the analysis): * Arthroscopically confirmed full-thickness tear of the supraspinatus and/or infraspinatus * Tear size greater than 3 cm in both anteroposterior and mediolateral dimensions, measured with a 5-mm graduated probe * Incomplete footprint coverage after maximal repair (less than 50% of the footprint) or Yoo type II-III * Long head of the biceps tendon Lafosse grade 0-II, suitable for transposition Exclusion Criteria: * Preoperative: * Glenohumeral arthritis / cuff tear arthropathy Hamada grade IV or higher * Subscapularis tear Lafosse type V (complete tear with humeral head decentering and Goutallier grade 3-4) * Previous surgery of the affected shoulder or shoulder deformity * Axillary nerve palsy or cervical nerve root injury * Shoulder joint infection * Neuromuscular conditions affecting postoperative rehabilitation (Parkinson disease, stroke with motor sequelae, severe dementia) * Refusal to participate or inability to comply with follow-up * Intraoperative: * Posterosuperior tear that cannot be repaired to the footprint to any degree after maximal release (irreparable) * Subscapularis tear of any Lafosse type that cannot be repaired to the footprint after maximal release * Long head of the biceps tendon Lafosse grade III, completely ruptured, or not suitable for transposition Participants who consented but meet an intraoperative exclusion criterion receive the most appropriate alternative procedure, are informed after surgery, and are not included in the analysis.

Locations (1)

Tam Anh TP. Ho Chi Minh General Hospital

Ho Chi Minh City, Ho Chi Minh, Vietnam