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