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