Mechanically or Kinematically Aligned Total Knee Prosthesis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique du Sport, Bordeaux Mérignac

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: patients with kinematic aligned knee prosthesisExperimental treatment 1 intervention
Group B: patients with biomechanic aligned knee prosthesisActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Biomechanical parameters of knee : spatiotemporal parameters

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

Time frame
One year after surgery
2

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

Time frame
One year after surgery
3

Biomechanical parameters of knee : joint moments

Unit : Newton meter

Time frame
One year after surgery
4

Biomechanical parameters of knee : force

Unit : body weight

Time frame
One year after surgery

Secondary outcomes

1

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

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

Time frame
One year after surgery
2

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

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)

Time frame
One year after surgery
3

Clinical results : Patient-Reported Outcome Measures: pain

visual analog scale (VAS) pain (numerical scale 0-10), 0 is absence of pain and 10 the worst pain possible

Time frame
One year after surgery
4

Clinical results : Patient satisfaction

Scale from "not at all satisfied" to "very satisfied"

Time frame
One year after surgery

Other outcomes

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