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New treatment option for Rotator Cuff Tears
Official title BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
ClinicalTrials.gov ID: NCT05997381
What this study is testing
- What it's testing
- This study aims to evaluate the safety and effectiveness of arthroscopic rotator cuff repair augmented with the BioBrace® Implant vs. arthroscopic rotator cuff repair alone in subjects requiring surgical intervention for a full-thickness rotator cuff tear.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Male or female 40 to 70 years old
- Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder indicating a full thickness rotator cuff tear (RCT):
- Tear of the supraspinatus and/or infraspinatus tendons
- Tear size ≥ 2 cm and \< 5 cm
- Chronic shoulder pain ≥ 3 months
You likely can't join if
- Previous surgery of the index shoulder one year prior to the study surgery excluding diagnostic arthroscopy
- Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 (Goutallier Score)
- Major medical condition that could affect quality of life and influence the results of the study as determined by the Investigator
- Oral steroid use or steroid injection within 6 weeks prior to surgery
- Active smoker
- History of insulin-dependent diabetes
See the full eligibility criteria
- Male or female 40 to 70 years old
- Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder indicating a full thickness rotator cuff tear (RCT):
- Tear of the supraspinatus and/or infraspinatus tendons
- Tear size ≥ 2 cm and \< 5 cm
- Chronic shoulder pain ≥ 3 months
- Failed non-operative treatment of the index shoulder to include one or all of the following:
- Oral analgesics
- Nonsteroidal anti-inflammatory medications (NSAIDs)
- Corticosteroid injections
- Activity modifications
- Physical therapy or home-guided exercises
- Able to read and understand the study REB/IRB approved Informed Consent Form (ICF)
- Willing to be available to attend each protocol-required follow-up examination Intraoperative
- Full thickness tear of the supraspinatus and/or infraspinatus tendons
- Tear size ≥ 2 cm and \< 5 cm
- Able to reapproximate the tendons to cover \> 50% of the footprint on the greater tuberosity
- Previous surgery of the index shoulder one year prior to the study surgery excluding diagnostic arthroscopy
- Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 (Goutallier Score)
- Major medical condition that could affect quality of life and influence the results of the study as determined by the Investigator
- Oral steroid use or steroid injection within 6 weeks prior to surgery
- Active smoker
- History of insulin-dependent diabetes
- Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
- Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)
- Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder
- History of claustrophobia that would prevent an MRI of the index shoulder
- Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study
- Currently participating, or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator
- History of non-compliance with medical treatment or clinical trial participation
- The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be...
- Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator
- The subject is receiving prescription narcotic pain medication
- The subject currently has an acute infection in the area surrounding the surgical site
- Contralateral shoulder condition where rotator cuff repair is scheduled or to be scheduled over the course of this study
- The subject's condition represents a worker's compensation case Intraoperative Exclusion Criteria: 1\. Subject requires subscapularis repair other than a repair with a single anchor
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 40 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. 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.