临床试验/NCT02976285

NCT02976285已完成不适用

Application of a New Polyester Patch in Arthroscopic Massive Rotator Cuff Repair Significantly Improves Clinical Outcome and Tendon Integrity

Etzel Clinic0 个研究点目标入组 54 人开始时间: 2012年6月最近更新: 2016年11月29日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 54
主要终点: Function assessed with the Subjective Shoulder Value

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study was to assess the impact and potential advantage of a novel synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and radiological approaches. The investigators hypothesized that implanting this patch will improve individual shoulder function, while reducing re-tear rates compared to the current literature.

详细描述

To evaluate this, patches were implanted into 54 shoulders and prospectively followed up clinically and radiologically.

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: 40 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Inclusion criteria were age greater 18 years and a RC tear involving at least two tendons, presenting a massive RC-tear as described by Gerber et al.

排除标准

•We excluded patients older than 75, fatty infiltration grade 4 according to Goutallier, re-ruptures of former repairs and cases with severe osteoarthritis.

结局指标

主要结局

Function assessed with the Subjective Shoulder Value

时间窗: 25 months

Function assessed with the Constant-Murley-Score

时间窗: 25 months

次要结局

Tendon integrity evaluated radiologically(1-35 months)

研究者

发起方

Etzel Clinic

申办方类型

Other

责任方

Sponsor

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