Osteoarthritis, Knee
Conditions
Keywords
total knee prosthesis, mechanical alignment, kinematic alignment, biomechanic study
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.
Interventions
DEVICEkinematic 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.
DEVICEbiomechanic 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).
Sponsors
Clinique du Sport, Bordeaux Mérignac
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biomechanical parameters of knee : spatiotemporal parameters | One year after surgery | When walking on flat ground and when going up/down stairs: walking speed |
| Biomechanical parameters of knee : Kinematic parameters in the 3 planes of space | One year after surgery | dynamic hip-knee-ankle angles during the knee flexion/extension test with and without support |
| Biomechanical parameters of knee : joint moments | One year after surgery | Unit : Newton meter |
| Biomechanical parameters of knee : force | One year after surgery | Unit : body weight |
| Biomechanical parameters of knee : lever arms | One year after surgery | — |
| Symmetry index between the operated limb and the healthy controlateral limb | One year after surgery | Comparison between the two limbs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical results : Patient-Reported Outcome Measures: Functional score (OXFORD scale) | One year after surgery | OXFORD scale : numerical rating scale used to quantify the power or strength produced by the contraction of a muscle (0-5) ; 5 is maximal strenght |
| Clinical results : Patient-Reported Outcome Measures: joint perception score | One year after surgery | Forgotten joint score : joint-specific questionnaire that focuses on the patients' awareness of their prosthetic joint during daily activities ; 0-100 (0 is the worst result and 100 the better result possible) |
| Clinical results : Patient-Reported Outcome Measures: pain | One year after surgery | visual analog scale (VAS) pain (numerical scale 0-10), 0 is absence of pain and 10 the worst pain possible |
| Clinical results : Patient satisfaction | One year after surgery | Scale from "not at all satisfied" to "very satisfied" |
| Clinical results : range of mobility of the prosthetic knee | One year after surgery | Range of motion from hyperextension to flexion (degrees) |
| Clinical results : complication rate | One year after surgery | Complication rate (percentage) : manipulation under anesthesia, re-operation, revision, previous pain syndrome |
| Imaging results : EOS 3D, alignement of the lower limb | One year after surgery | measurement of the frontal alignment of the lower limb (hip-knee-ankle and hip-knee-calcaneus angles) |
| Imaging results : EOS 3D, orientation of the implants | One year after surgery | \- measurement of the orientation of the implants in the frontal (medial proximal tibial, lateral distal femoral and joint line convergence angles) and sagittal (tibial slope, flexion of the femoral component) planes |
| Imaging results : EOS 3D, distance between anterior femoral cortex and prosthetic trochlea | One year after surgery | measurement of the distance between the anterior femoral cortex and the prosthetic trochlea |
| Imaging results : radiography, evaluation of implant fixation | One year after surgery | evaluation of implant fixation (e.g. sealing, border, reactive line) |
| Imaging results : radiography, measurement of patellar height | One year after surgery | measurement of patellar height (pre- and post-op Caton-Deschamps index comparison) |
| Imaging results : radiography, evaluation of the bone structure | One year after surgery | evaluation of bone structure (e.g. osteolysis) |
Countries
France
Contacts
CONTACTCharles Rivière, MD
Outcome results
None listed