NCT05925881 Lower Trapezius Transfer vs Bridging Reconstruction
| NCT ID | NCT05925881 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nova Scotia Health Authority |
| Condition | Rotator Cuff Tears |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-10-30 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05925881 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rotator Cuff Tears. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05925881 currently recruiting?
Yes, NCT05925881 is actively recruiting participants. Visit ClinicalTrials.gov or contact Nova Scotia Health Authority to inquire about joining.
Where is the NCT05925881 trial being conducted?
This trial is being conducted at Halifax, Canada.
Who is sponsoring the NCT05925881 clinical trial?
NCT05925881 is sponsored by Nova Scotia Health Authority. The trial plans to enroll 60 participants.