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
CONMED Corporation
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.
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 usi…
Eligibility
- Age range
- 40–70 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion 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 ho…
Interventions
- DeviceArthroscopic 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.
- ProcedureArthroscopic rotator cuff repair
An arthroscopic rotator cuff repair is performed using standard surgical procedure.
Location
- ConMedNew Haven, Connecticut