Clinical trial NCT06158646: Mechanically or Kinematically Aligned Total Knee Prosthesis
Official title: Mechanically or Kinematically Aligned Total Knee Prosthesis: Prospective and Comparative Study of Clinical, Stereoradiographic, and Biomechanical Results
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: total knee prosthesis
mechanical alignment
kinematic alignment
biomechanic study
Lead sponsor: Clinique du Sport, Bordeaux Mérignac
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Biomechanical parameters of knee : spatiotemporal parameters
timeFrame: One year after surgery
measure: Biomechanical parameters of knee : Kinematic parameters in the 3 planes of space
timeFrame: One year after surgery
measure: Biomechanical parameters of knee : joint moments
timeFrame: One year after surgery
measure: Biomechanical parameters of knee : force
timeFrame: One year after surgery
measure: Biomechanical parameters of knee : lever arms
timeFrame: One year after surgery
measure: Symmetry index between the operated limb and the healthy controlateral limb
timeFrame: One year after surgery
Secondary outcomes:
measure: Clinical results : Patient-Reported Outcome Measures: Functional score (OXFORD scale)
timeFrame: One year after surgery
measure: Clinical results : Patient-Reported Outcome Measures: joint perception score
timeFrame: One year after surgery
measure: Clinical results : Patient-Reported Outcome Measures: pain
timeFrame: One year after surgery
measure: Clinical results : Patient satisfaction
timeFrame: One year after surgery
measure: Clinical results : range of mobility of the prosthetic knee
timeFrame: One year after surgery
measure: Clinical results : complication rate
timeFrame: One year after surgery
measure: Imaging results : EOS 3D, alignement of the lower limb
timeFrame: One year after surgery
measure: Imaging results : EOS 3D, orientation of the implants
timeFrame: One year after surgery
measure: Imaging results : EOS 3D, distance between anterior femoral cortex and prosthetic trochlea
timeFrame: One year after surgery
measure: Imaging results : radiography, evaluation of implant fixation
timeFrame: One year after surgery
measure: Imaging results : radiography, measurement of patellar height
timeFrame: One year after surgery
measure: Imaging results : radiography, evaluation of the bone structure
timeFrame: One year after surgery
Other outcomes:
Locations:
city: Mérignac
country: France
facility: Clinique du Sport Bordeaux Merignac
Study officials:
References: