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

Last updated: October 3, 2024
Sponsor: Clinique du Sport, Bordeaux Mérignac
Overall Status: Active - Recruiting

Phase

N/A

Condition

Osteoarthritis

Knee Injuries

Treatment

SPHERIKA prosthesis

ORIGIN prosthesis

Clinical Study ID

NCT06603103
2023-21-SBM
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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) beforethe first research examination.

Exclusion

Exclusion Criteria:

  • Patient with complex osteoarthritis (e.g. bone loss, history of patellarinstability)

  • Patient with contralateral knee prosthesis

  • Patient with symptomatic osteoarthritis (stiffness and/or pain) of a hip orcontralateral knee

  • Patient with another condition (acquired pathology) of the lower limbs and/ornervous 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.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: SPHERIKA prosthesis
Phase:
Study Start date:
October 03, 2024
Estimated Completion Date:
April 30, 2028

Connect with a study center

  • Clinique du Sport

    Merignac, 33000
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.