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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: SPHERIKA prosthesis; Procedure: ORIGIN prosthesis

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charles Rivière, MD; Phone Number: +335 56 46 32 33; Email: charles.riviere@bari-arthroplasty.com

Study Locations

• France
  • Mérignac, France, 33000
    • Recruiting
    • Clinique du Sport
    • Contact: Charles Rivière, MD; Email: charles.riviere@bari-arthroplasty.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: total knee arthroplasty with kinematic alignment and SPHERIKA prosthesis	Procedure: SPHERIKA prosthesis; total knee arthroplasty with kinematic alignement with SPHERIKA prosthesis
Experimental: total knee arthroplasty with kinematic alignment and ORIGIN prosthesis	Procedure: ORIGIN prosthesis; total knee arthroplasty with kinematic alignement with ORIGIN prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of "forgotten joint score"	This score consists in 12 questions with a Likert scale from 0 to 5. A high score indicates a high degree of forgetfulness of the prosthesis on the part of the patient.	2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frontal alignment of the lower limb		2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery
Walking ability	Evaluation of walking ability : walking speed, cadence, stride length, stride duration	2 years after surgery
Evaluation of muscular strength	Measure of : Maximum force developed (N); Explosivity (time required to develop maximum force, N/s); Power (cumulative force developed during the entire acquisition period, W)	2 years after surgery

Collaborators and Investigators

• Sponsor: Clinique du Sport, Bordeaux Mérignac

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Total knee arthroplasty; biomechanics; kinematic alignment; joint perception
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2023-21-SBM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No