Lower Trapezius Transfer vs Bridging Reconstruction
Recruiting now · Not applicable
Conditions studied: Rotator Cuff Tears
In brief
The goal of this clinical trial is to compare the bridging reconstruction technique vs the lower trapezius tendon transfer in patients with massive irreparable rotator cuff tears. The main questions it aims to answer are: * comparing the outcomes of the two surgical techniques (BRR with an acellular human dermal allograft implant vs Arthroscopic Assisted LTT Transfer) on the maintenance of the acromiohumeral distance * compare the outcomes of strength, range of motion, and patient reported quality of life scores between the two techniques Participants will be randomized into one of two surgical treatment groups (bridging reconstruction or lower trapezius tendon transfer) and followed for a minimum of two years to compare the outcomes between groups.
Key facts
- Study ID
- NCT05925881
- Run by
- Nova Scotia Health Authority
- People needed
- 60
- Starts
- 2023-10-30
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2025-02-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- 5955 Veterans' Memorial Lane Room 2106, VMB — Halifax, Nova Scotia, Canada (enrolling)
Full record on ClinicalTrials.gov
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