RECRUITING

BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears

Conditions

Rotator Cuff Tears Rotator cuff tear Full thickness tear BioBrace

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-01-05

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05997381

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.

Ages Eligible for Study:40 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Male or female 40 to 70 years old 2. Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder indicating a full thickness rotator cuff tear (RCT): 1. Tear of the supraspinatus and/or infraspinatus tendons 2. Tear size ≥ 2 cm and \< 5 cm 3. Chronic shoulder pain ≥ 3 months 4. Failed non-operative treatment of the index shoulder to include one or all of the following: 1. Oral analgesics 2. Nonsteroidal anti-inflammatory medications (NSAIDs) 3. Corticosteroid injections 4. Activity modifications 5. Physical therapy or home-guided exercises 5. Able to read and understand the study REB/IRB approved Informed Consent Form (ICF) 6. Willing to be available to attend each protocol-required follow-up examination	1. Previous surgery of the index shoulder one year prior to the study surgery excluding diagnostic arthroscopy 2. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 (Goutallier Score) 3. Major medical condition that could affect quality of life and influence the results of the study as determined by the Investigator 4. Oral steroid use or steroid injection within 6 weeks prior to surgery 5. Active smoker 6. History of insulin-dependent diabetes 7. Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment 8. Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG) 9. Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder 10. History of claustrophobia that would prevent an MRI of the index shoulder 11. Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study 12. 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 13. History of non-compliance with medical treatment or clinical trial participation 14. 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 15. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator 16. The subject is receiving prescription narcotic pain medication 17. The subject currently has an acute infection in the area surrounding the surgical site 18. Contralateral shoulder condition where rotator cuff repair is scheduled or to be scheduled over the course of this study 19. The subject's condition represents a worker's compensation case

Inclusion Criteria

Exclusion Criteria

1. Male or female 40 to 70 years old
2. Positive diagnostic imaging by MRI within 6 months of enrollment of the index shoulder indicating a full thickness rotator cuff tear (RCT):
1. Tear of the supraspinatus and/or infraspinatus tendons
2. Tear size ≥ 2 cm and \< 5 cm
3. Chronic shoulder pain ≥ 3 months
4. Failed non-operative treatment of the index shoulder to include one or all of the following:
1. Oral analgesics
2. Nonsteroidal anti-inflammatory medications (NSAIDs)
3. Corticosteroid injections
4. Activity modifications
5. Physical therapy or home-guided exercises
5. Able to read and understand the study REB/IRB approved Informed Consent Form (ICF)
6. Willing to be available to attend each protocol-required follow-up examination

1. Previous surgery of the index shoulder one year prior to the study surgery excluding diagnostic arthroscopy
2. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3 (Goutallier Score)
3. Major medical condition that could affect quality of life and influence the results of the study as determined by the Investigator
4. Oral steroid use or steroid injection within 6 weeks prior to surgery
5. Active smoker
6. History of insulin-dependent diabetes
7. Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment
8. Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)
9. Presence of an implanted metallic device or other implants that would contraindicate acquisition or inhibit radiologist review of an MRI of the index shoulder
10. History of claustrophobia that would prevent an MRI of the index shoulder
11. Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study
12. 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
13. History of non-compliance with medical treatment or clinical trial participation
14. 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
15. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator
16. The subject is receiving prescription narcotic pain medication
17. The subject currently has an acute infection in the area surrounding the surgical site
18. Contralateral shoulder condition where rotator cuff repair is scheduled or to be scheduled over the course of this study
19. The subject's condition represents a worker's compensation case

Contacts and Locations

Study Contact

Evona Wojtanowski

CONTACT

BioBraceRCT@ConMed.com

Study Locations (Sites)

ConMed

New Haven, Connecticut, 06513

United States

Collaborators and Investigators

Sponsor: CONMED Corporation

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 Registration Dates

Study Start Date2024-01-05

Study Completion Date2027-06

Study Record Updates

Study Start Date2024-01-05

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

Rotator cuff tear
Full thickness tear
BioBrace

Additional Relevant MeSH Terms

Rotator Cuff Tears