Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06603103

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

Led by Clinique du Sport, Bordeaux Mérignac · Updated on 2026-04-01

120

Participants Needed

1

Research Sites

186 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Clinique du Sport

Mérignac, France, 33000

Actively Recruiting

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Research Team

C

Charles Rivière, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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