Evaluation of a new navigation system for knee surgery
Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty
This study is testing a new computer-assisted navigation system for knee surgery to see if it helps people with knee arthritis recover better than traditional surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (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 | NCT05435690 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new navigation system designed for computer-assisted total knee arthroplasty in patients with gonarthrosis. It is a single-blind, randomized, prospective comparative study that involves two groups: one receiving conventional arthroplasty and the other receiving the computer-assisted approach. Patients will be assessed at three different time points: before the surgery, three months post-surgery, and twelve months post-surgery to determine the effectiveness of the new navigation system. The goal is to improve surgical outcomes and patient recovery.
Who should consider this trial
Good fit: Ideal candidates are adults with primary uni or bilateral gonarthrosis who are indicated for total knee arthroplasty.
Not a fit: Patients with a history of knee fractures, previous arthroplasty, or severe preoperative conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical precision and better recovery outcomes for patients undergoing knee arthroplasty.
How similar studies have performed: Other studies have shown promising results with computer-assisted techniques in orthopedic surgery, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult man or woman who has signed the informed consent for participation in the study, * Patient with primary uni or bilateral gonarthrosis * For whom an indication for total knee arthroplasty has been given Exclusion Criteria: * History of fracture, arthroplasty or osteotomy of the knee * Severe preoperative laxity warranting a constrained prosthesis * Inflammatory rheumatic disease or any other progressive concomitant condition that may impact on the patient's functional prognosis * Traumatic articular or extra-articular deformities of the lower limb * Neurological disease, after-effects of a stroke * Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol * Patient not affiliated to the French social security system * Patient under legal protection, guardianship or curatorship * Patient already included in another therapeutic study protocol or having participated in another trial in the previous three months
Where this trial is running
Lyon
- Hôpital Privé Jean Mermoz — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Jean LANGLOIS, MD
- Email: jeangast@gmail.com
- Phone: 0603294533
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.