- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05997381
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears (REinForce)
May 6, 2024 updated by: CONMED Corporation
REinForce: A Prospective, Single Blind, Multi-Center, Randomized, Controlled, Pivotal Study to Evaluate the Safety and Effectiveness of the BioBrace® Implant During Arthroscopic Repair of Full Thickness Rotator Cuff Tears
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.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
This is a prospective, single blind, multi-center, randomized, controlled, pivotal clinical study investigating the treatment of full thickness tears of the rotator cuff.
Tears must involve the supraspinatus and/or infraspinatus tendons and measure ≥ 2 cm and < 5 cm.
Subjects meeting the inclusion/exclusion criteria will be enrolled and will undergo either arthroscopic rotator cuff repair augmented with the BioBrace® Implant or arthroscopic rotator cuff repair alone.
Clinical evaluations will be conducted at baseline (pre-operatively) and at 6 weeks, 3-, 6-, and 12-months post-operatively using various patient-reported outcome measures and MRI to assess repair integrity and re-tear rate.
Study Type
Interventional
Enrollment (Estimated)
268
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06513
- ConMed
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion 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 Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 unable or unlikely to remain compliant with protocol required follow-up
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BioBrace Augment Group
An arthroscopic rotator cuff repair is performed with the BioBrace Implant fixed on top of the repaired tendon using anchors.
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An arthroscopic rotator cuff repair will be performed and augmented with the BioBrace® Implant.
The BioBrace® Implant is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists.
It is a bioresorbable, biocomposite scaffold composed of a highly porous collagen sponge and reinforced with poly-L-lactic-acid (PLLA).
When used in rotator cuff repairs, it is placed on top of the tendons to augment and reinforce the underlying repair.
The BioBrace® is designed to mechanically and biologically augment weakened or torn soft tissue and can be integrated into surgeons' standard of care rotator cuff repair techniques.
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Sham Comparator: Repair Only Group
An arthroscopic rotator cuff repair is performed using standard surgical procedure.
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An arthroscopic rotator cuff repair is performed using standard surgical procedure.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 Month Retear Rate
Time Frame: 6 months post-op
|
The between-group difference in radiological incidence (MRI) of a Sugaya Type IV or V full-thickness discontinuity at postoperative Month 6.
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6 months post-op
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
12 Month Retear Rate
Time Frame: 12 months post-op
|
The between-group difference in radiological incidence (MRI) of Sugaya Type IV or V full-thickness discontinuity at postoperative Month 12.
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12 months post-op
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Single Assessment Numeric Evaluation (SANE)
Time Frame: Baseline, 6 weeks, 3-, 6-, and 12-months post-op
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Adjusted mean between-group difference in SANE score from baseline to 6 weeks, 3-, 6-, and 12-months post-op
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Baseline, 6 weeks, 3-, 6-, and 12-months post-op
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Western Ontario Rotator Cuff Index (WORC)
Time Frame: Baseline, 6 weeks, 3-, 6-, and 12-months post-op
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Adjusted mean between-group difference in WORC score from baseline to 6 weeks, 3-, 6-, and 12-months post-op
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Baseline, 6 weeks, 3-, 6-, and 12-months post-op
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EuroQOL Five Dimensions Questionnaire (EQ-5D-5L)
Time Frame: Baseline, 6 weeks, 3-, 6-, and 12-months post-op
|
Adjusted mean between-group difference in health-related, quality of life from baseline to 6 weeks, 3-, 6-, and 12-months post-op
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Baseline, 6 weeks, 3-, 6-, and 12-months post-op
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
August 10, 2023
First Submitted That Met QC Criteria
August 10, 2023
First Posted (Actual)
August 18, 2023
Study Record Updates
Last Update Posted (Actual)
May 7, 2024
Last Update Submitted That Met QC Criteria
May 6, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSP-BB0003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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