Mechanically or Kinematically Aligned Total Knee Prosthesis

NCT06158646 | Recruiting

• 1 other identifier: 2023-A01312-43
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

total knee prosthesis; mechanical alignment; kinematic alignment; biomechanic study

Outcome Measures

Primary Outcomes (6)

• Biomechanical parameters of knee : spatiotemporal parameters

  When walking on flat ground and when going up/down stairs: walking speed

  One year after surgery

• Biomechanical parameters of knee : Kinematic parameters in the 3 planes of space

  dynamic hip-knee-ankle angles during the knee flexion/extension test with and without support

  One year after surgery

• Biomechanical parameters of knee : joint moments

  Unit : Newton meter

  One year after surgery

• Biomechanical parameters of knee : force

  Unit : body weight

  One year after surgery

• Biomechanical parameters of knee : lever arms

  One year after surgery

• Symmetry index between the operated limb and the healthy controlateral limb

  Comparison between the two limbs

  One year after surgery

Secondary Outcomes (12)

• Clinical results : Patient-Reported Outcome Measures: Functional score (OXFORD scale)

  One year after surgery

• Clinical results : Patient-Reported Outcome Measures: joint perception score

  One year after surgery

• Clinical results : Patient-Reported Outcome Measures: pain

  One year after surgery

• Clinical results : Patient satisfaction

  One year after surgery

• Clinical results : range of mobility of the prosthetic knee

  One year after surgery

Study Arms (2)

patients with kinematic aligned knee prosthesis

EXPERIMENTAL

Device: kinematic knee prosthesis

patients with biomechanic aligned knee prosthesis

ACTIVE COMPARATOR

Device: biomechanic knee prosthesis

Interventions

kinematic knee prosthesis 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 kinematic aligned knee prosthesis

biomechanic knee prosthesis 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).

patients with biomechanic aligned knee prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique du Sport, Bordeaux Mérignac: lead

Study Sites (1)

Clinique du Sport Bordeaux Merignac

Mérignac, 33700, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Charles Rivière, MD

CONTACT

+33 5 56 46 10 40; charles.riviere@bari-arthroplasty.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 6, 2023
• Study Start: October 5, 2023
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)