Rotator cuff repair with biceps rerouting and dermal graft augmentation for large, difficult tears

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, single-arm study enrolling adults aged 40–75 with large-to-massive posterosuperior rotator cuff tears. All participants undergo maximal arthroscopic repair, transposition of the long head of the biceps tendon, and augmentation with an acellular dermal matrix graft, followed by a standardized rehabilitation program. The primary outcome is tendon retear on MRI at 12 months; secondary outcomes include pain, shoulder function scores, range of motion, strength, radiographic findings, and safety. There is no comparison group in this design. The study is conducted at Tam Anh General Hospital in Ho Chi Minh City as part of a doctoral project at Hue University of Medicine and Pharmacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tam Anh TP. Ho Chi Minh General Hospital
  Ho Chi Minh City, Ho Chi Minh, Vietnam Recruiting

Study contacts

• Study coordinator: Duy Ân Văn Hồ, M.D., M.Sc.
• Email: anhvd@tahospital.vn
• Phone: +84839412663

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.