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临床试验/NCT04658459
NCT04658459Unknown不适用

Proximal Interphalangeal Joint Arthroplasty With the TACTYS® Prosthesis : Clinical and Radiographic Results at Medium Term.

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
force in kilograms

研究概览

简要总结

Study at middle term of the functional and radiographic results of proximal interphalangeal joint arthroplasty with the Tactys prothesis. The aim is to evaluate if the short term results are maintained in time.

详细描述

The inclusion criteria is any patient who has undergone a proximal interphalangeal joint arthroplasty with the Tactys prothesis between january 2015 to january 2020 in the Centre Chirurgical Emile Gallé in Nancy.

The functional results evaluated are range of motion, force, pain, functional score as Quick DASH and the radiological one are clinodactyly, periprosthetic ossifications and loosening, dislocation and implant subsidence.

Data is registered from the medical folder of every patient.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • one or more proximal interphalangeal joint arthroplasty of long fingers with the Tactys prosthesis
  • between january 2015 to january 2020
  • centre chirurgical emile gallé, centre hospitalier régional universitaire de Nancy

排除标准

  • 未提供

结局指标

主要结局

force in kilograms

时间窗: minimal one year post-operative

measurement of force with jamar and pinch tests in kilograms

range of motion in degrees

时间窗: minimal one year post-operative

measurement of range of motion in degrees

pain with the digital pain scale

时间窗: minimal one year post-operative

measurement of pain with the digital pain scale to zero to ten

functional score with the Quick DASH

时间窗: minimal one year post-operative

measurement of the quick-DASH functional score to zeo to hundred

次要结局

  • assess satisfaction(minimal one year post-operative)
  • register the complication and their apparition in time(minimal one year post-operative)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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