Mechanically or Kinematically Aligned Total Knee Prosthesis

Osteoarthritis, Knee Clinical Trial

— BIOMAKA  

Official title:

Mechanically or Kinematically Aligned Total Knee Prosthesis: Prospective and Comparative Study of Clinical, Stereoradiographic, and Biomechanical Results

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158646
• Other study ID #: 2023-A01312-43
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: Clinique du Sport, Bordeaux Mérignac
• Contact: Charles Rivière, MD
• Phone: +33 5 56 46 10 40
• Email: charles.riviere[@]bari-arthroplasty.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 30, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Device:
• kinematic 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.
• biomechanic 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).

Locations

Country	Name	City	State
France	Clinique du Sport Bordeaux Merignac	Mérignac

Sponsors (1)

Lead Sponsor	Collaborator
Clinique du Sport, Bordeaux Mérignac

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomechanical parameters of knee : spatiotemporal parameters	When walking on flat ground and when going up/down stairs: walking speed	One year after surgery
Primary	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
Primary	Biomechanical parameters of knee : joint moments	Unit : Newton meter	One year after surgery
Primary	Biomechanical parameters of knee : force	Unit : body weight	One year after surgery
Primary	Biomechanical parameters of knee : lever arms		One year after surgery
Primary	Symmetry index between the operated limb and the healthy controlateral limb	Comparison between the two limbs	One year after surgery
Secondary	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	One year after surgery
Secondary	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)	One year after surgery
Secondary	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	One year after surgery
Secondary	Clinical results : Patient satisfaction	Scale from "not at all satisfied" to "very satisfied"	One year after surgery
Secondary	Clinical results : range of mobility of the prosthetic knee	Range of motion from hyperextension to flexion (degrees)	One year after surgery
Secondary	Clinical results : complication rate	Complication rate (percentage) : manipulation under anesthesia, re-operation, revision, previous pain syndrome	One year after surgery
Secondary	Imaging results : EOS 3D, alignement of the lower limb	measurement of the frontal alignment of the lower limb (hip-knee-ankle and hip-knee-calcaneus angles)	One year after surgery
Secondary	Imaging results : EOS 3D, orientation of the implants	- 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	One year after surgery
Secondary	Imaging results : EOS 3D, distance between anterior femoral cortex and prosthetic trochlea	measurement of the distance between the anterior femoral cortex and the prosthetic trochlea	One year after surgery
Secondary	Imaging results : radiography, evaluation of implant fixation	evaluation of implant fixation (e.g. sealing, border, reactive line)	One year after surgery
Secondary	Imaging results : radiography, measurement of patellar height	measurement of patellar height (pre- and post-op Caton-Deschamps index comparison)	One year after surgery
Secondary	Imaging results : radiography, evaluation of the bone structure	evaluation of bone structure (e.g. osteolysis)	One year after surgery