跳至主要内容
临床试验/NCT07313449
NCT07313449招募中不适用

Study of the Clinical and Radiographic Results of a Fixed Polyethylene Posteriorly Stabilized Cemented Total Knee Prosthesis With a Minimum Follow-up of 1 Year.

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 960 人开始时间: 2025年1月31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
960
试验地点
1
主要终点
IKS / KSS (Knee Society Score)

研究概览

简要总结

The knee replacement market is experiencing constant growth. Alongside this growth, there is also an increasing interest in customizing implantation based on specific phenotypes to restore the morphology of the native knee. For example, in the last five years, 2019 publications on knee prosthesis alignment have been identified on PubMed.

It seems worthwhile to study and analyze the performance of the prosthesis used in the Orthopedic Surgery Department of the Strasbourg University Hospitals (HUS) and to compare it with results from the literature.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Adult patient
  • Patient who underwent total knee replacement (TKR) between January 2013 and December 2024
  • Patient who underwent an Anatomic, Amplitude, posteriorly stabilized, fixed polyethylene, cemented TKR
  • Patient operated on by Professor F. Bonnomet
  • Available radiological data: preoperative, immediate postoperative, and postoperative at a minimum of 1 year follow-up

排除标准

  • - Revision of the arthroplasty during the study follow-up period for a cause not investigated in the study

结局指标

主要结局

IKS / KSS (Knee Society Score)

时间窗: Up to 12 months

The classic IKS (often called KSS) has 2 separate scores, each out of 100 points: 1. Knee Score (Objective / Clinical) - 0 to 100 Assesses the knee itself: * Pain (0-50) * Range of motion (0-25) * Stability (0-25) 2. Function Score - 0 to 100 * Assesses patient function: * Walking distance (0-50) * Stair climbing (0-50) Interpretation (commonly used): * 80-100: Excellent * 70-79: Good * 60-69: Fair * \< 60: Poor

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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