Prospective Randomized Study Comparing the SpheriKA® (MEDACTA) and Origin® (SYMBIOS) Prostheses During Total Knee Replacement Using the Kinematic Alignment Technique (KAOR)

Clinique du Sport, Bordeaux Mérignac

Status

Enrolling

Conditions

Knee Osteoarthritis

Treatments

Procedure: ORIGIN prosthesis

Procedure: SPHERIKA prosthesis

Study type

Interventional

Funder types

Other

Identifiers

NCT06603103

2023-21-SBM

Details and patient eligibility

About

The traditional technique for implanting a total knee prosthesis, known as mechanical alignment, does not aim to preserve the original anatomy and laxity of the knee. Instead, the implants are "systematically" aligned to create a non-naturally straight lower limb. Respectively 20% and 50% of patients with a mechanically aligned total knee prosthesis are dissatisfied with the result, and complain of residual symptoms. A newer, more physiological technique for implanting a total knee prosthesis, known as kinematic alignment, aims to recreate the unique native anatomy and laxity of each patient's knee. The kinematic alignment technique has been shown to reduce the risk of residual symptoms and thus improve the patient's experience of his or her prosthetic knee. As a result of the emergence of the kinematic alignment technique, two manufacturers have developed total knee prosthesis implants specifically for this new insertion technique. A "made-to-measure" total knee prosthesis (ORIGIN® - Symbios, Yverdon-les-Bains, Switzerland) was developed with the aim of reproducing the unique contour of each implanted knee. Another manufacturer opted to develop a generic total knee prosthesis implant (SPHERIKA® - Medacta, Castel San Pietro, Switzerland), but with a design optimized for the kinematic alignment technique. These two models of total knee prosthesis each offer advantages and limitations that need to be assessed. The main aim of this study is therefore to compare the joint perception of these 2 prostheses. It will also look at the clinical and imaging results, the biomechanics of the prosthetic knee during gait, and the muscular strength of knee extension, obtained for these 2 total knee prostheses.

Enrollment

120 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with indication for initial total knee replacement
Patient affiliated to a social security scheme
Patient informed of the study and formally included (informed consent signed) before the first research examination.

Exclusion criteria

Patient with complex osteoarthritis (e.g. bone loss, history of patellar instability)
Patient with contralateral knee prosthesis
Patient with symptomatic osteoarthritis (stiffness and/or pain) of a hip or contralateral knee
Patient with another condition (acquired pathology) of the lower limbs and/or nervous system that may significantly affect gait quality
Patient deprived of liberty by judicial or administrative decision,
Patient of legal age under legal protection or unable to express consent.