Comparing two surgical techniques for massive rotator cuff 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 clinical trial aims to compare the outcomes of two surgical techniques for treating massive irreparable rotator cuff tears: bridging reconstruction using an acellular human dermal allograft and lower trapezius tendon transfer. A total of 60 patients will be randomized into one of the two treatment groups and followed for a minimum of two years. The study will assess the maintenance of acromiohumeral distance, strength, range of motion, and patient-reported quality of life scores. Pre-operative evaluations will include MRI and structured clinical examinations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* magnetic resonance imaging (MRI) proven diagnosis of a massive rotator cuff tear
* tear size \>5cm
* two-tendon, irreparable tear
* competent adult (\>18 years of age)
* \<50% muscle atrophy.

Exclusion Criteria:

* irreparable subscapular tear
* glenohumeral osteoarthritis
* WORC score \> 70
* uncontrolled diabetes (Hgb A1C \>7%)
* pregnancy
* presence of local or systemic infection
* inability to cooperate with and/or comprehend post-operative instructions
* cancer
* paralysis of the shoulder
* contracture of the shoulder
* inability to provide informed consent

Where it's running

• 5955 Veterans' Memorial Lane Room 2106, VMB
  Halifax, Nova Scotia, Canada Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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

  This study tests a combined surgical approach to see if it helps tendon retear rates in adults with large rotator cuff tears that are hard to repair.

  Recruiting Tam Anh Research Institute · Ho Chi Minh City, Ho Chi Minh · NCT07875556

• Biomarkers to see if rotator cuff repairs will heal after surgery

  This study tests whether biomarkers in shoulder tissue and synovial fluid can predict whether a rotator cuff repair will heal, using MRI after surgery to compare those who heal with those who don’t.

  Recruiting University of Iowa · Iowa City, Iowa · NCT07781553

• Mobilization with Movement for people with rotator cuff lesions

  This trial will test whether Mobilization with Movement helps reduce pain, improve shoulder function, and restore joint position sense in adults with rotator cuff lesions.

  Recruiting Kirsehir Ahi Evran Universitesi · Kırşehir · NCT07383038

• Does age-related muscle loss change rotator cuff tear patterns?

  We will see if age-related muscle loss (sarcopenia) is linked to the location and type of rotator cuff tears in adults aged 40–75 with rotator cuff syndrome.

  Recruiting Haydarpasa Numune Training and Research Hospital · Istanbul, Üsküdar · NCT07183774

• Impact of neck nerve compression (cervical radiculopathy) on recovery after rotator cuff repair

  This study sees if people under 65 who had cervical radiculopathy before rotator cuff repair have different shoulder function and quality of life after surgery compared with those who did not.

  Recruiting Biruni University · Istanbul, Istanbul · NCT07001566

• Using virtual reality to help rehabilitate shoulder injuries

  This study tests whether using virtual reality can make shoulder rehabilitation more engaging and effective for people with shoulder injuries.

  Recruiting La Tour Hospital · Meyrin, Canton of Geneva · NCT06963983

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.