NCT00739947已完成不适用
A PROSPECTIVE STUDY TO EVALUATE SURGICAL OUTCOMES IN SUBJECTS WITH FULL-THICKNESS ROTATOR CUFF TEARS TREATED BY MEANS OF A DOUBLE-ROW ARTHROSCOPIC REPAIR.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 162
- 试验地点
- 29
- 主要终点
- The primary objective is to observe the rate and timing of tendon retear in subjects with full thickness rotator cuff tears (RCTs) treated by means of arthroscopic surgery.
研究概览
简要总结
This is an observational study that involves subjects with full-thickness rotator cuff tears treated by means of arthroscopy surgical repair, also known as arthroscopic surgery. The primary objective of this study is to observe the timing and rate of tendon retear in those subjects.
详细描述
Subjects will be recruited from each surgeon's surgical practice. They will be reviewed to assure they meet all eligibility criteria prior to enrolling them into the study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full thickness Rotator Cuff Tears ranging from 1cm to 4cm in size.
- •Planned procedure for repair is tendon-to-bone repair by means of an arthroscopy
排除标准
- •Previous surgical intervention to the shoulder joint understudy
- •Tears of the subscapularis or labral pathology requiring surgical repair
- •Shoulder instability either shoulder
- •Unable to complete functional evaluations in either shoulder
结局指标
主要结局
The primary objective is to observe the rate and timing of tendon retear in subjects with full thickness rotator cuff tears (RCTs) treated by means of arthroscopic surgery.
时间窗: 1 year
次要结局
- Evaluation of the ability to define(1 year)
- Determine the correlation of functional outcomes over time in subjects with retears compared with subjects who have an intact cuff repair using the Constant Murley Shoulder Score as well as strength and range of motion.(1 year)
- Determination of the correlation between imaging biomarkers (muscle atrophy and fatty infiltration) and the subjects outcome (retear and function).(1 year)
- Estimation of the relationship between patient reported outcomes and subject's surgical and functional outcomes.(1 year)
- Observation of any comorbidity associated with the arthroscopic surgical procedure through the collection of adverse events to provide and SOC reference for future safety studies.(1 year)
研究者
研究点 (29)
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