Cleveland Clinic ActivBraid Rotator Cuff Repair (RCR) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Rotator cuff repair healing
研究概览
简要总结
We will enroll up to 65 patients undergoing primary arthroscopic rotator cuff repair (RCR) using ActivBraid™Collagen Co-Braid suture (Zimmer Biomet) and evaluate RCR healing as well as shoulder range of motion, strength, and patient-reported outcomes at 6m, 1y and 2y.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years
- •acute or chronic, reparable, 1-5 cm full thickness tear of the supraspinatus and/or infraspinatus tendons
排除标准
- •prior ipsilateral shoulder surgery
- •outstanding worker's compensation claim
- •symptomatic cervical spine disease
- •a frozen shoulder
- •advanced glenohumeral arthritis
- •isolated subscapularis tear
- •significant radiation exposure for other medical reasons.
- •known is advance to be claustrophobic
- •known history of hypersensitivity to bovine-derived materials.
研究组 & 干预措施
patients undergoing primary arthroscopic rotator cuff repair
Patients undergoing primary arthroscopic rotator cuff repair will have their repair completed with ActivBraid™Collagen Co-Braid suture (Zimmer Biomet).
干预措施: ActivBraid™Collagen Co-Braid suture (Zimmer Biomet) (Device)
结局指标
主要结局
Rotator cuff repair healing
时间窗: 1 year post-operation
Patients will undergo magnetic resonance imaging (MRI) of the shoulder from which healing of their rotator cuff repair will be classified using Sugaya score from 1-5, where higher score indicated worse healing.
次要结局
- Patient-reported outcome measures(1 year post-operation)
- Shoulder strength(1 year post-operation)
- Shoulder range of motion(1 year post-operation)
研究者
Kathleen Derwin, PhD
Associate Staff Scientist
The Cleveland Clinic