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

NCT ID: NCT06603103

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-03
• Study Completion Date: 2028-04-30

Brief Summary

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

total knee arthroplasty with kinematic alignment and SPHERIKA prosthesis

Group Type: EXPERIMENTAL

SPHERIKA prosthesis

Intervention Type: PROCEDURE

total knee arthroplasty with kinematic alignement with SPHERIKA prosthesis

total knee arthroplasty with kinematic alignment and ORIGIN prosthesis

Group Type: EXPERIMENTAL

ORIGIN prosthesis

Intervention Type: PROCEDURE

total knee arthroplasty with kinematic alignement with ORIGIN prosthesis

Interventions

SPHERIKA prosthesis

total knee arthroplasty with kinematic alignement with SPHERIKA prosthesis

Intervention Type: PROCEDURE

ORIGIN prosthesis

total knee arthroplasty with kinematic alignement with ORIGIN prosthesis

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinique du Sport, Bordeaux Mérignac

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique du Sport

Mérignac, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Charles Rivière, MD

Role: CONTACT

charles.riviere@bari-arthroplasty.com

+335 56 46 32 33

Facility Contacts

Charles Rivière, MD

Role: primary

charles.riviere@bari-arthroplasty.com

Other Identifiers

2023-21-SBM

Identifier Type: -

Identifier Source: org_study_id