Rotation MEdical BioindUctive ImpLant Database (REBUILD) Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 483
- 试验地点
- 19
- 主要终点
- American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
研究概览
简要总结
The purpose of this clinical registry is to prospectively collect and compare preoperative and postoperative patient-reported data using validated shoulder-specific and health-related quality of life (QoL) instruments during real-world use of the Rotation Medical bioinductive implant to treat rotator cuff tears.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 21 years of age.
- •Able and willing to provide voluntary consent to Registry participation.
- •Able to read, speak, and understand the English language.
排除标准
- •Hypersensitive to bovine-derived materials.
结局指标
主要结局
American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
时间窗: 1 year
Change between baseline and post-operative ASES shoulder score over time.
Western Ontario Rotator Cuff Index (WORC)
时间窗: 1 Year
Change between baseline and post-operative WORC score over time.
Shoulder pain
时间窗: 1 year
Change between baseline and post-operative shoulder pain over time using a Visual Analog Scale (VAS).
Single Assessment Numeric Evaluation (SANE) Score
时间窗: 1 year
Change between baseline and post-operative SANE score over time.
Veterans RAND 12 Item Health Survey (VR-12)
时间窗: 1 year
Change between baseline and post-operative VR-12 score over time.
次要结局
- Recovery by cumulative number of days shoulder is in a sling(1 Year)
- Recovery by cumulative number corticosteroid injections used to manage post-operative shoulder pain.(1 Year)
- Safety assessed by number of Adverse Events and Serious Adverse Events.(1 Year)
- Recovery by cumulative time between discharge and return to driving(1 Year)
- Recovery by cumulative number physical therapy (PT) visits to rehabilitate the index shoulder.(1 Year)
- Recovery by cumulative number of days of narcotic medication use to manage post-operative shoulder pain.(1 Year)
- Recovery by cumulative time in days between discharge and return to work.(1 Year)
- Recovery by cumulative time days between discharge and return to overhead-throwing and non-overhead throwing sports(1 Year)
- Revision Surgery(1 Year)