跳至主要内容
临床试验/NCT05734651
NCT05734651招募中不适用

Prospective Evaluation of the PROMIS Stem for Primary Total Hip Arthroplasty

Bezirkskrankenhaus St. Johann in Tirol1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Stem Migration

研究概览

简要总结

A total of 250 total hip arthroplasties (THA) are performed at the Bezirkskrankenhaus St. Johann. In a majority of those, implants from the company Falcon Medical (Austria) are used. Those implants are undergoing constant development and improvement. To guarantee their clinical performance, this clinical study is evaluating safety and efficacy of all implants produced by Falcon Medical.

The purpose of this study is to evaluate the effcacy and safety of implants produced and distributed by Falcon Medical. All patients with primary THA and usage of a Falcon Medical implant are included. The outcome measures include intra-operative complications, early post-operative complications, revision for any cause and patient reported outcome (WOMAC questionnaire). All data is prospectively collected in a standardized fashion.

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

入选标准

  • Primary total hip arthroplasty with the PROMIS stem

排除标准

  • 未提供

结局指标

主要结局

Stem Migration

时间窗: 20 years

Stem Migration measured with the validated EBRA method. The stem migration is assessed in millimeters. The radiograph before surgery and sequential radiographs after surgery are assessed.

次要结局

  • WOMAC Score(20 years)

研究者

发起方
Bezirkskrankenhaus St. Johann in Tirol
申办方类型
Other
责任方
Principal Investigator
主要研究者

Moritz Wagner

Principal Investigator

Bezirkskrankenhaus St. Johann in Tirol

研究点 (1)

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