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NCT06158646 | RECRUITING | Osteoarthritis, Knee

Mechanically or Kinematically Aligned Total Knee Prosthesis
Sponsor:

Sports Clinic, Bordeaux Mérignac

Brief 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.

Condition or disease

Osteoarthritis, Knee

Intervention/treatment

kinematic knee prosthesis

biomechanic knee prosthesis

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Mechanically or Kinematically Aligned Total Knee Prosthesis: Prospective and Comparative Study of Clinical, Stereoradiographic, and Biomechanical Results
Actual Study Start Date : 2023-10-05
Estimated Primary Completion Date : 2025-08-31
Estimated Study Completion Date : 2025-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Mechanically or Kinematically Aligned Total Knee Prosthesis

Location Details

NCT06158646

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How to Participate

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Locations

RECRUITING

France,

Bordeaux Merignac Sports Clinic

Mérignac, France, 33700