NCT06158646: BIOMAKA

Mechanically or Kinematically Aligned Total Knee Prosthesis

Recruiting now NA Last updated 6 April 2026

What this trial tests

NA trial testing kinematic knee prosthesis in Osteoarthritis, Knee in 120 participants. Currently enrolling.

Timeline

5 October 2023

Primary endpoint
31 August 2027

30 September 2027

Quick facts

Lead sponsor	Clinique du Sport, Bordeaux Mérignac
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	5 October 2023
Primary completion	31 August 2027
Estimated completion	30 September 2027
Sites	1 location across France

Drugs / interventions tested

• kinematic knee prosthesis
• biomechanic knee prosthesis

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

Clinique du Sport, Bordeaux Mérignac

Who can join

18 and older, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.