Actively Recruiting
Maximal Repair Versus Bridging Reconstruction with BioBrace®
Led by Nova Scotia Health Authority · Updated on 2025-02-18
60
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
Sponsors
N
Nova Scotia Health Authority
Lead Sponsor
C
CONMED Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.
CONDITIONS
Official Title
Maximal Repair Versus Bridging Reconstruction with BioBrace®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- MRI confirmed large or massive (> 3cm) two-tendon tear (supraspinatus and infraspinatus) of the shoulder rotator cuff
- Age 18 years or older
You will not qualify if you...
- Glenohumeral osteoarthritis
- Western Ontario rotator cuff score greater than 60
- Uncontrolled diabetes (Hemoglobin A1C > 7%)
- Pregnancy
- Local or systemic infection
- Inability to cooperate with or understand post-operative instructions
- MRI showing non-vascular sites
- Poor nutritional status (Albumin < 30 g/L)
- Cancer
- Shoulder paralysis
- Shoulder contracture
- Unable to provide informed consent for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H2E1
Actively Recruiting
Research Team
S
Sarah Remedios, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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