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

NCT06603103 | Recruiting

• 1 other identifier: 2023-21-SBM
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Total knee arthroplasty; kinematic alignment; joint perception; biomechanics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Frontal alignment of the lower limb

  2 months before surgery ; 45 days after surgery ; 1 year after surgery ; 2 years after surgery

• Walking ability

  2 years after surgery

• Evaluation of muscular strength

  2 years after surgery

Study Arms (2)

total knee arthroplasty with kinematic alignment and SPHERIKA prosthesis

EXPERIMENTAL

Procedure: SPHERIKA prosthesis

total knee arthroplasty with kinematic alignment and ORIGIN prosthesis

EXPERIMENTAL

Procedure: ORIGIN prosthesis

Interventions

SPHERIKA prosthesis PROCEDURE

total knee arthroplasty with kinematic alignement with SPHERIKA prosthesis

total knee arthroplasty with kinematic alignment and SPHERIKA prosthesis

ORIGIN prosthesis PROCEDURE

total knee arthroplasty with kinematic alignement with ORIGIN prosthesis

total knee arthroplasty with kinematic alignment and ORIGIN prosthesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique du Sport, Bordeaux Mérignac: lead

Study Sites (1)

Clinique du Sport

Mérignac, 33000, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Charles Rivière, MD

CONTACT

+335 56 46 32 33; charles.riviere@bari-arthroplasty.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: October 3, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)