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Mechanically or Kinematically Aligned Total Knee Prosthesis - Trial NCT06158646

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Trial Details
ClinicalTrials.govNCT06158646
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Mechanically or Kinematically Aligned Total Knee Prosthesis
Mechanically or Kinematically Aligned Total Knee Prosthesis: Prospective and Comparative Study of Clinical, Stereoradiographic, and Biomechanical Results

Study Focus

Osteoarthritis, Knee

kinematic knee prosthesis

Interventional

device

Sponsor & Location

Clinique du Sport, Bordeaux Mérignac

Mérignac, France

Timeline & Enrollment

N/A

Oct 05, 2023

Sep 30, 2024

120 participants

Primary Outcome

Biomechanical parameters of knee : spatiotemporal parameters,Biomechanical parameters of knee : Kinematic parameters in the 3 planes of space,Biomechanical parameters of knee : joint moments,Biomechanical parameters of knee : force,Biomechanical parameters of knee : lever arms,Symmetry index between the operated limb and the healthy controlateral limb

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.

ICD-10 Classifications

Chronic instability of knee
Injuries to the knee and lower leg
Gonarthrosis [arthrosis of knee]
Dislocation, sprain and strain of joints and ligaments of knee
Sprain and strain of other and unspecified parts of knee

Data Source

ClinicalTrials.gov

NCT06158646

Device Trial