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Clinical Trials in France / NCT06158646
Recruiting Not applicable

Mechanically or Kinematically Aligned Total Knee Prosthesis

NCT06158646 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-10-05
Last updated
2026-04-06

Condition(s) studied

Osteoarthritis, Knee

Investigational drug(s) / intervention(s)

kinematic knee prosthesisbiomechanic knee prosthesis

kinematic knee prosthesis: Patients 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: A 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).

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Clinique du Sport Bordeaux Merignac Mérignac France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06158646 on ClinicalTrials.gov ↗ ← All trials in France