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临床试验/NCT06158646
NCT06158646
招募中
不适用

Mechanically or Kinematically Aligned Total Knee Prosthesis: Prospective and Comparative Study of Clinical, Stereoradiographic, and Biomechanical Results

Clinique du Sport, Bordeaux Mérignac2 个研究点 分布在 1 个国家目标入组 120 人2023年10月5日

概览

阶段
不适用
干预措施
kinematic knee prosthesis
疾病 / 适应症
Osteoarthritis, Knee
发起方
Clinique du Sport, Bordeaux Mérignac
入组人数
120
试验地点
2
主要终点
Biomechanical parameters of knee : force
状态
招募中
最后更新
26天前

概览

简要总结

The mechanical alignment technique (Mechanical Alignment - MA) of a total knee prosthesis (TKA) was developed with the aim of making the installation of a TKA simple and reproducible, and that the prosthetic biomechanics are acceptable, thus promoting good longevity of implants. This is a technique that does not aim to restore the constitutional anatomy of the knee; bone cuts are systematically made at fixed angles, in the 3 planes of space, in relation to the mechanical axes of the long bones (femur and tibia). This non-personalized implantation technique therefore systematically alters the anatomy, laxity and kinematics of the knee, causing up to 50% of residual symptoms after prosthetic implantation and 20% of dissatisfied patients.

In order to improve the clinical results of TKA, a new, more personalized and physiological technique was developed in 2007, called Kinematic Alignment (KA). This technique aims to restore the pre-arthritic anatomy, unique to each knee. Patients with severe constitutional deformity of the lower limb therefore retain this deformity after kinematic prosthetic replacement. The impact of the alignment technique on the biomechanics of the prosthetic knee remains poorly described. The main objective of this study is therefore to compare knee biomechanics between mechanical TKA and kinematic TKA.

注册库
clinicaltrials.gov
开始日期
2023年10月5日
结束日期
2027年9月30日
最后更新
26天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Clinique du Sport, Bordeaux Mérignac
责任方
Sponsor

入排标准

入选标准

  • Patient followed as part of a consultation 1 year after TKA placement
  • Adult patient
  • Patient affiliated to a social security system
  • Patient informed of the study and formally included (signing of informed consent) before the first research review

排除标准

  • Patient with a contralateral knee prosthesis
  • Patient with another condition (acquired pathology) of the lower limbs (e.g. severe osteoarthritis of the contralateral knee or hip/ankle) and/or of the nervous system (e.g. Parkinson's) which may significantly affect the quality of walking
  • Pregnant patient
  • Patient deprived of liberty by judicial or administrative decision,
  • Adult patient subject to a legal protection measure or unable to express consent

研究组 & 干预措施

patients with kinematic aligned knee prosthesis

干预措施: kinematic knee prosthesis

patients with biomechanic aligned knee prosthesis

干预措施: biomechanic knee prosthesis

结局指标

主要结局

Biomechanical parameters of knee : force

时间窗: One year after surgery

Unit : body weight

Biomechanical parameters of knee : lever arms

时间窗: One year after surgery

Biomechanical parameters of knee : spatiotemporal parameters

时间窗: One year after surgery

When walking on flat ground and when going up/down stairs: walking speed

Biomechanical parameters of knee : joint moments

时间窗: One year after surgery

Unit : Newton meter

Biomechanical parameters of knee : Kinematic parameters in the 3 planes of space

时间窗: One year after surgery

dynamic hip-knee-ankle angles during the knee flexion/extension test with and without support

Symmetry index between the operated limb and the healthy controlateral limb

时间窗: One year after surgery

Comparison between the two limbs

次要结局

  • Clinical results : Patient-Reported Outcome Measures: Functional score (OXFORD scale)(One year after surgery)
  • Clinical results : Patient-Reported Outcome Measures: pain(One year after surgery)
  • Clinical results : Patient satisfaction(One year after surgery)
  • Clinical results : complication rate(One year after surgery)
  • Clinical results : Patient-Reported Outcome Measures: joint perception score(One year after surgery)
  • Clinical results : range of mobility of the prosthetic knee(One year after surgery)
  • Imaging results : EOS 3D, alignement of the lower limb(One year after surgery)
  • Imaging results : EOS 3D, distance between anterior femoral cortex and prosthetic trochlea(One year after surgery)
  • Imaging results : radiography, evaluation of implant fixation(One year after surgery)
  • Imaging results : radiography, measurement of patellar height(One year after surgery)
  • Imaging results : radiography, evaluation of the bone structure(One year after surgery)
  • Imaging results : EOS 3D, orientation of the implants(One year after surgery)

研究点 (2)

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