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

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

Overview

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.

Interventions

• Device 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
• Procedure Arthroscopic rotator cuff repair
  An arthroscopic rotator cuff repair is performed using standard surgical procedure.

Primary outcome measures

• 6 Month Retear Rate [Time frame: 6 months post-op]

Secondary outcome measures (4)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• ConMed — New Haven

Identifiers

NCT: NCT05997381 · CSP-BB0003

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗