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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Clinique du Sport
RECRUITING
Mérignac
Contact Information
Primary
Charles Rivière, MD
charles.riviere@bari-arthroplasty.com
+335 56 46 32 33
Time Frame
Start Date: 2024-10-03
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 120
Treatments
Experimental: total knee arthroplasty with kinematic alignment and SPHERIKA prosthesis
Experimental: total knee arthroplasty with kinematic alignment and ORIGIN prosthesis
Sponsors
Leads: Clinique du Sport, Bordeaux Mérignac

This content was sourced from clinicaltrials.gov