Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Radiographic or clinical failure
研究概览
简要总结
The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be unaware to the type of surgery that they received. The investigator will not be blinded, however, the individuals assessing the outcomes will be.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •magnetic resonance imaging (MRI) proven diagnosis of a large or massive (> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
- •over 18 years of age
排除标准
- •glenohumeral osteoarthritis
- •Western Ontario rotator cuff score >60
- •uncontrolled diabetes (Hgb A1C >7%)
- •local or systemic infection
- •inability to cooperate with and/or comprehend post-operative instructions
- •MRI proven non-vascular sites
- •poor nutritional state (Alb <30 g/L)
- •paralysis of the shoulder
- •contracture of the shoulder
- •patients unable to provide informed consent for the study
结局指标
主要结局
Radiographic or clinical failure
时间窗: 2 years
The primary outcome measure for this study will be radiographic and/or clinical failure defined as a rotator cuff tear of equal or larger size than at baseline or does not meet WORC score MCID compared to baseline at any follow up
次要结局
- Western Ontario Rotator Cuff Index (WORC)(Baseline, 6-month, 1-year, 2-years)
- Muscle Atrophy(2 year)
- Acromiohumeral Distance(2 year)
- Fatty Infiltration(2 year)
- Healing Rate(2 year)
- American Shoulder and Elbow Surgeon survey(Baseline, 6-month, 1-year, 2-years)
- EQ-5D-5L(Baseline, 6-month, 1-year, 2-years)
- Range of motion(Baseline, 6-month, 1-year, 2-years)
- Shoulder strength(Baseline, 6-month, 1-year, 2-years)
- Biomechanics and Muscle Activity(Baseline and 2 years)
研究者
Ivan Wong, MD
MD Orthopaedic Surgeon
Nova Scotia Health Authority