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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- 6 Month Retear Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BioBrace Augment Group
An arthroscopic rotator cuff repair is performed with the BioBrace Implant fixed on top of the repaired tendon using anchors.
干预措施: Arthroscopic rotator cuff repair with BioBrace® Implant augmentation. (Device)
Repair Only Group
An arthroscopic rotator cuff repair is performed using standard surgical procedure.
干预措施: Arthroscopic rotator cuff repair (Procedure)
结局指标
主要结局
6 Month Retear Rate
时间窗: 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.
次要结局
- 12 Month Retear Rate(12 months post-op)
- Western Ontario Rotator Cuff Index (WORC)(Baseline, 6 weeks, 3-, 6-, and 12-months post-op)
- Single Assessment Numeric Evaluation (SANE)(Baseline, 6 weeks, 3-, 6-, and 12-months post-op)
- EuroQOL Five Dimensions Questionnaire (EQ-5D-5L)(Baseline, 6 weeks, 3-, 6-, and 12-months post-op)