临床试验/NCT03727490

NCT03727490已完成不适用

The Role of Subscapularis Repair in Reverse Shoulder Arthroplasty

Washington University School of Medicine1 个研究点分布在 1 个国家目标入组 102 人开始时间: 2018年12月1日最近更新: 2025年12月31日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Washington University School of Medicine
入组人数: 102
试验地点: 1
主要终点: American Shoulder and Elbow Surgeons Score

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The overall goal of the study is to determine if repairing the subscapularis tendon during primary reverse shoulder arthroplasty effects short-term patient outcomes. The study is a patient blinded randomized controlled trial that is currently enrolling.

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, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Adults undergoing primary reverse shoulder arthroplasty

排除标准

•Adults without an intact subscapularis
•Inflammatory arthritis
•Revision surgery

研究组 & 干预措施

Control

Active Comparator

This group will have the subscapularis left un-repaired, which is the standard of care for our institution for reverse shoulder arthroplasty.

干预措施: Standard Treatment (Other)

Study

Experimental

This group will have the subscapularis tendon repaired through a bone to bone repair that will add approximately 5 minutes to the surgical procedure.

干预措施: Repair (Other)

结局指标

主要结局

American Shoulder and Elbow Surgeons Score

时间窗: Two Years

Patient Reported Outcome

次要结局

Simple Shoulder Test(Two Years)

研究者

发起方

Washington University School of Medicine

申办方类型

Other

责任方

Sponsor

研究点 (1)

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