Rotator Cuff TearsREinForceNCT05997381
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
A study testing Arthroscopic rotator cuff repair with BioBrace® Implant augmentation. and Arthroscopic rotator cuff repair in people with Rotator Cuff Tears, run by CONMED Corporation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- Arthroscopic rotator cuff repair with BioBrace® Implant augmentation. and Arthroscopic rotator cuff repair
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rotator Cuff Tears
- Being tested
- Arthroscopic rotator cuff repair with BioBrace® Implant augmentation., Arthroscopic rotator cuff repair
- Keywords
- Rotator cuff tear, Full thickness tear, BioBrace
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic rotator cuff repair with BioBrace® Implant augmentation.Device
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.
Arthroscopic rotator cuff repairProcedure or surgery
An arthroscopic rotator cuff repair is performed using standard surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| BioBrace Augment Group | Experimental | An arthroscopic rotator cuff repair is performed with the BioBrace Implant fixed on top of the repaired tendon using anchors. Receives: Device: Arthroscopic rotator cuff repair with BioBrace® Implant augmentation. |
| Repair Only Group | Sham comparator | An arthroscopic rotator cuff repair is performed using standard surgical procedure. Receives: Procedure: Arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Month Retear Rate
The between-group difference in radiological incidence (MRI) of a Sugaya Type IV or V full-thickness discontinuity at postoperative Month 6.
Measured: 6 months post-op
Secondary outcomes (4)
12 Month Retear Rate
The between-group difference in radiological incidence (MRI) of Sugaya Type IV or V full-thickness discontinuity at postoperative Month 12.
Measured: 12 months post-op
Single Assessment Numeric Evaluation (SANE)
Adjusted mean between-group difference in SANE score from baseline to 6 weeks, 3-, 6-, and 12-months post-op
Measured: Baseline, 6 weeks, 3-, 6-, and 12-months post-op
Western Ontario Rotator Cuff Index (WORC)
Adjusted mean between-group difference in WORC score from baseline to 6 weeks, 3-, 6-, and 12-months post-op
Measured: Baseline, 6 weeks, 3-, 6-, and 12-months post-op
EuroQOL Five Dimensions Questionnaire (EQ-5D-5L)
Adjusted mean between-group difference in health-related, quality of life from baseline to 6 weeks, 3-, 6-, and 12-months post-op
Measured: Baseline, 6 weeks, 3-, 6-, and 12-months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start5 Jan 2024
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CONMED Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997381
- Sponsor's protocol ID
- CSP-BB0003
- Acronym
- REinForce
- Status last verified
- Oct 2026
- First submitted
- 10 Aug 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05997381
- Acronym / sponsor ID
- REinForce / CSP-BB0003
- Conditions
- Rotator Cuff Tears
- Keywords
- Rotator cuff tear, Full thickness tear, BioBrace
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- CONMED CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioBrace Augment Group | Experimental | Device: Arthroscopic rotator cuff repair with BioBrace® Implant augmentation.An arthroscopic rotator cuff repair is performed with the BioBrace Implant fixed on top of the repaired tendon using anchors. |
| Repair Only Group | Sham comparator | Procedure: Arthroscopic rotator cuff repairAn arthroscopic rotator cuff repair is performed using standard surgical procedure. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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):
- Chronic shoulder pain ≥ 3 months
- Failed non-operative treatment of the index shoulder to include one or all of the following:
- Able to read and understand the study REB/IRB approved Informed Consent Form (ICF)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic rotator cuff repair with BioBrace® Implant augmentation.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. | Device | BioBrace Augment Group |
| Arthroscopic rotator cuff repairAn arthroscopic rotator cuff repair is performed using standard surgical procedure. | Procedure or surgery | Repair Only Group |
Primary outcome
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.
4 secondary outcomes
12 Month Retear Rate
Time frame: 12 months post-op
Single Assessment Numeric Evaluation (SANE)
Time frame: Baseline, 6 weeks, 3-, 6-, and 12-months post-op
Western Ontario Rotator Cuff Index (WORC)
Time frame: Baseline, 6 weeks, 3-, 6-, and 12-months post-op
EuroQOL Five Dimensions Questionnaire (EQ-5D-5L)
Time frame: Baseline, 6 weeks, 3-, 6-, and 12-months post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic rotator cuff repair with BioBrace® Implant augmentation. and Arthroscopic rotator cuff repair in people with Rotator Cuff Tears, run by CONMED Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Month Retear Rate (time frame: 6 months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.