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临床试验/NCT05928403
NCT05928403招募中不适用

Rate of Return to Sport After Total Knee Prosthesis: Comparison of Three Different Types of Prostheses (Medial Pivot, Medial Bearing and Cruciate Retaining)

GCS Ramsay Santé pour l'Enseignement et la Recherche2 个研究点 分布在 1 个国家目标入组 660 人开始时间: 2024年6月11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
660
试验地点
2
主要终点
rate of return to sport

研究概览

简要总结

The purpose of the study is the rate of return to sport (regardless of the sport envisaged) after a minimum of 3 years after total knee prosthesis.

详细描述

This is an ambispective, comparative study of three cohorts, non-randomized, open, monocentric, relating to the return to sport of patients who have benefited from one of the three designs of prostheses under study (medial pivot, medial bearing and cruciate retaining) after total knee prosthesis.

Patients who received a total knee prosthesis with medial pivot, medial bearing and cruciate retaining prosthesis between 2018 and 2020 will be called by the investigator, and the study will be offered to them (D-3 to D0). The investigator will explain the study to the patient, send him the information note electronically and answer all his questions about the study. If the patient agrees to participate after a reflection period, the inclusion (D0) will be documented in the medical file, and the patient will be assessed the same day by telephone using the assessments set up in the study, except for the questionnaires on his functional and physical abilities that will be sent to him electronically. The patient will return his answers to the questionnaires on this same email address or by telephone according to his preference. A secure and unique email address will be created by the principal investigator for the purposes of the study and for use strictly specific to the study, in the investigating center.

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First total knee prosthesis between 2018 and 2020;
  • Conventional alignment technique using the same surgical technique for total knee prosthesis;
  • Placement of a medial pivot prosthesis (Evolution®), mobile bearing (SCORE® Amplitude) or traditional cruciate retaining prosthesis (Stryker® Triathlon);
  • Affiliation to a social security scheme;
  • Patient having been informed and having given his oral non-objection

排除标准

  • Bilateral total knee prosthesis;
  • Medical history of revision of Total Knee Prosthesis;
  • Articulation malformation of the lower limbs;
  • Having undergone revision surgery;
  • Inability to understand information related to the study for linguistic, psychological, cognitive reasons;
  • Patient under legal protection, or deprived of liberty by judicial or administrative decision.

结局指标

主要结局

rate of return to sport

时间窗: 3 years

rate of return to sport after a minimum of 3 years after total knee prosthesis

次要结局

未报告次要终点

研究者

发起方
GCS Ramsay Santé pour l'Enseignement et la Recherche
申办方类型
Other
责任方
Sponsor

研究点 (2)

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