Mechanically or Kinematically Aligned Total Knee Prosthesis (BIOMAKA)

Clinique du Sport, Bordeaux Mérignac

Status: Enrolling

Conditions: Osteoarthritis, Knee

Treatments: Device: biomechanic knee prosthesis; Device: kinematic knee prosthesis

Study type: Interventional

Funder types: Other

Identifiers

NCT06158646

2023-A01312-43

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

patients with kinematic aligned knee prosthesis

Experimental group

Treatment:

Device: kinematic knee prosthesis

patients with biomechanic aligned knee prosthesis

Active Comparator group

Treatment:

Device: biomechanic knee prosthesis