About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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,
Trial design
Parallel
Treatments tested in this trial
kinematic knee prosthesis
DevicePatients with a kinematically aligned total knee prosthesis and having a post-operative follow-up consultation within at least 1 year after their surgery are consecutively pre-selected according to the eligibility criteria.
biomechanic knee prosthesis
DeviceA group of patients with a mechanically aligned TKA and scheduled for a follow-up consultation 1 year after surgery will be identified to be matched on the aforementioned criteria (sex, age, BMI).
Treatment groups
Trial outcomes
Primary outcomes
Biomechanical parameters of knee : spatiotemporal parameters
When walking on flat ground and when going up/down stairs: walking speed
Biomechanical parameters of knee : Kinematic parameters in the 3 planes of space
dynamic hip-knee-ankle angles during the knee flexion/extension test with and without support
Biomechanical parameters of knee : joint moments
Unit : Newton meter
Biomechanical parameters of knee : force
Unit : body weight
Secondary outcomes
Clinical results : Patient-Reported Outcome Measures: Functional score (OXFORD scale)
OXFORD scale : numerical rating scale used to quantify the power or strength produced by the contraction of a muscle (0-5) ; 5 is maximal strenght
Clinical results : Patient-Reported Outcome Measures: joint perception score
Forgotten joint score : joint-specific questionnaire that focuses on the patients' awareness of their prosthetic joint during daily activities ; 0-100 (0 is the worst result and 100 the better result possible)
Clinical results : Patient-Reported Outcome Measures: pain
visual analog scale (VAS) pain (numerical scale 0-10), 0 is absence of pain and 10 the worst pain possible
Clinical results : Patient satisfaction
Scale from "not at all satisfied" to "very satisfied"
Sponsors and contacts
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