Mechanically or Kinematically Aligned Total Knee Prosthesis

NCT ID: NCT06158646

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-05
• Study Completion Date: 2025-09-30

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patients with kinematic aligned knee prosthesis

Group Type: EXPERIMENTAL

kinematic knee prosthesis

Intervention Type: DEVICE

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.

patients with biomechanic aligned knee prosthesis

Group Type: ACTIVE_COMPARATOR

biomechanic knee prosthesis

Intervention Type: DEVICE

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).

Interventions

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.

Intervention Type: DEVICE

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).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique du Sport, Bordeaux Mérignac

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique du Sport Bordeaux Merignac

Mérignac, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Charles Rivière, MD

Role: CONTACT

charles.riviere@bari-arthroplasty.com

+33 5 56 46 10 40

Facility Contacts

Charles Rivière, MD

Role: primary

charles.riviere@bari-arthroplasty.com

+33 5 56 46 10 40

Other Identifiers

2023-A01312-43

Identifier Type: -

Identifier Source: org_study_id