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RECRUITING

NCT07875556

Arthroscopic Rotator Cuff Repair With Long Head of Biceps Transposition 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 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 Incomplete Repair of Large-to-Massive Rotator Cuff Tears 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

2026-10-19

Healthy Volunteers

Conditions

Rotator Cuff Tears Rotator Cuff Injuries Massive Rotator Cuff Tear

Interventions

PROCEDURE

Rotator Cuff Repair

Arthroscopic repair of the posterosuperior rotator cuff to the maximum achievable footprint coverage after release of adhesions, using double-loaded medial-row suture anchors, with margin convergence and footprint medialization (up to 10 mm) when needed.

PROCEDURE

Long Head of the Biceps Tendon Transposition

The long head of the biceps tendon is released from the bicipital groove, transposed to the superior greater tuberosity and fixed with a double-loaded suture anchor placed 5 mm lateral to the articular margin, using two lasso-loop stitches.

DEVICE

Acellular Dermal Matrix (Allograft) Augmentation

A 2-mm-thick acellular dermal matrix graft, sized intraoperatively, is passed over the repair on the medial-row sutures and fixed laterally in a suture-bridge configuration with knotless lateral-row anchors. The device is registered in Vietnam as a Class D medical device (No. 2501939ĐKLH/BYT-HTTB).

Inclusion Criteria: * Preoperative: * Age 40 to 75 years * Large-to-massive 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