Comparing two types of knee implants during total knee replacement surgery
Prospective Randomized Study Comparing the SpheriKA® (MEDACTA) and Origin® (SYMBIOS) Prostheses During Total Knee Replacement Using the Kinematic Alignment Technique
NA · Clinique du Sport, Bordeaux Mérignac · NCT06603103
This study is testing two different knee implants to see which one helps people feel better and happier after total knee replacement surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Clinique du Sport, Bordeaux Mérignac (other) |
| Locations | 1 site (Mérignac) |
| Trial ID | NCT06603103 on ClinicalTrials.gov |
What this trial studies
This study compares the SpheriKA® and Origin® prostheses used in total knee replacement surgeries, focusing on a technique called kinematic alignment that aims to preserve the natural anatomy of the knee. The traditional mechanical alignment method often leads to patient dissatisfaction due to residual symptoms post-surgery. By utilizing kinematic alignment, the study seeks to improve patient outcomes and overall satisfaction with knee prosthetics. Patients will be randomly assigned to receive one of the two prostheses to evaluate their effectiveness.
Who should consider this trial
Good fit: Ideal candidates are patients requiring their first total knee replacement and who are affiliated with a social security scheme.
Not a fit: Patients with complex osteoarthritis or other significant lower limb conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient satisfaction and reduced residual symptoms after knee replacement surgery.
How similar studies have performed: Previous studies on kinematic alignment techniques have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Mérignac
- Clinique du Sport — Mérignac, France (RECRUITING)
Study contacts
- Study coordinator: Charles Rivière, MD
- Email: charles.riviere@bari-arthroplasty.com
- Phone: +335 56 46 32 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Osteoarthritis, Total knee arthroplasty, kinematic alignment, joint perception, biomechanics