跳至主要内容
临床试验/NCT03922763
NCT03922763Unknown不适用

Does a Fixed Inclination Humeral Cut in Anatomic Total Shoulder Arthroplasty Effectively Recreate Normal Anatomy: A Prospective Randomized Trial

Rothman Institute Orthopaedics2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年2月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Radriographic measurements

研究概览

简要总结

The purpose of the present study is to determine if a standard humeral cut using a fixed neck shaft angled prosthesis for patients undergoing anatomic TSA is able to restore normal glenohumeral relationships as compared to a variable neck shaft angle prosthesis.

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
None

入排标准

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

入选标准

  • patients 18 years or older
  • primary glenohumeral osteoarthritis
  • intact rotator cuff
  • primary anatomic shoulder arthroplasty

排除标准

  • revision arthroplasty
  • reverse shoulder arthroplasty candidates
  • cognitive or behavioral problems which would preclude informed consent

研究组 & 干预措施

Anatomically-matched cut

Active Comparator

干预措施: Anatomical cut (Procedure)

Cutting guide

Active Comparator

干预措施: Cutting guide (Procedure)

结局指标

主要结局

Radriographic measurements

时间窗: x-rays taken day of surgery

x-rays will be measured by 3 independent surgeons to measure restoration to natural anatomy following total shoulder replacement

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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