Comparing patient satisfaction with personalized versus conventional knee implants
Evaluation of the Impact of Customization of Total Knee Prostheses on Patient Satisfaction and Functional Outcome of Arthroplasty.
This study is testing whether personalized knee implants make people happier and feel better after knee surgery compared to regular implants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 480 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT04460989 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate patient satisfaction 24 months after total knee arthroplasty using either personalized or conventional prostheses. It is a prospective, randomized, monocentric, single-blind comparative study involving two parallel groups. The study will also assess functional outcomes, pain progression, quality of life, surgical conditions, and the frequency of adverse events related to the arthroplasty.
Who should consider this trial
Good fit: Ideal candidates are adults with uni- or bilateral primary gonarthrosis who are scheduled for total knee arthroplasty.
Not a fit: Patients with a history of knee arthroplasty, inflammatory diseases, or other conditions affecting functional prognosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient satisfaction and outcomes following knee arthroplasty.
How similar studies have performed: Previous studies have shown varying degrees of success with personalized implants, but this specific comparative approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult man or woman who has signed consent to participate in the study * Patient with uni- or bilateral primary gonarthrosis * For which an indication for total knee arthroplasty has been established Exclusion Criteria: * History of knee arthroplasty or osteotomy * History of knee fracture * Inflammatory rheumatic disease or any other progressive concomitant disease that may affect the patient's functional prognosis. * Joint or extra-articular deformities of the lower limb of traumatic origin * Neurological diseases, stroke sequelae * Mental disability or any other reason that may hinder the understanding or strict application of the protocol * Patient not affiliated to the French social security scheme * Patient under legal protection, guardianship or trusteeship * Patient already included in another therapeutic study protocol or having participated in another trial within the previous three months * Arthroplasty actually performed * Absence of per operative complications in bone (femoral or tibial bone), ligament (rupture or disinsertion of the patellar or quadricipital tendon) or nerve (lesion of the external popliteal sciatica).
Where this trial is running
Lyon
- Centre Orthopédique Santy — Lyon, France (Recruiting)
Study contacts
- Principal investigator: Michel Bonnin, Md — Centre Orthopédique Santy
- Study coordinator: Michel BONNIN, MD
- Email: bonnin.michel@gmail.com
- Phone: 04 37 53 00 26
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.