BridgeMD
Compares treatment options for Rotator Cuff Tears
Official title Maximal Repair Versus Bridging Reconstruction with BioBrace®
ClinicalTrials.gov ID: NCT05959733
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder...
- over 18 years of age
You likely can't join if
- glenohumeral osteoarthritis
- Western Ontario rotator cuff score \>60
- uncontrolled diabetes (Hgb A1C \>7%)
- pregnant
- local or systemic infection
- inability to cooperate with and/or comprehend post-operative instructions
See the full eligibility criteria
- magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
- over 18 years of age
- glenohumeral osteoarthritis
- Western Ontario rotator cuff score \>60
- uncontrolled diabetes (Hgb A1C \>7%)
- pregnant
- local or systemic infection
- inability to cooperate with and/or comprehend post-operative instructions
- MRI proven non-vascular sites
- poor nutritional state (Alb \<30 g/L)
- cancer
- paralysis of the shoulder
- contracture of the shoulder
- patients unable to provide informed consent for the study
The study team makes the final eligibility decision.
Where it's taking place
- Halifax, Nova Scotia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Halifax, Nova Scotia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.