Evaluation of a new all-ceramic knee prosthesis for knee osteoarthritis
Evaluation of a New Bi-Condylar Total Knee Prosthesis (TKP) With All-Ceramic Friction
This study is testing a new all-ceramic knee replacement to see if it can help younger people with knee osteoarthritis feel better and avoid more surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06592248 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new bi-condylar total knee prosthesis that utilizes an all-ceramic friction system, aiming to improve outcomes for patients with knee osteoarthritis. The research focuses on assessing clinical and radiological endpoints over a 12-month period, including functional scores, pain levels, knee mobility, and joint stability. The study aims to determine if this innovative prosthesis can enhance long-term survival rates and reduce the need for re-interventions in younger patients. Participants will undergo various assessments, including X-rays and MRI, to evaluate the effectiveness of the prosthesis.
Who should consider this trial
Good fit: Ideal candidates are active adults under 70 years old with disabling knee osteoarthritis that has not responded to medical treatments.
Not a fit: Patients with significant knee deformities, obesity, or other contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this new prosthesis could lead to improved pain management and functionality for patients suffering from knee osteoarthritis.
How similar studies have performed: While total knee prostheses have been widely studied, the specific use of an all-ceramic friction system in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Previously active adult under 70 years of age with disabling knee osteoarthritis resistant to medical treatments (anti-inflammatories, infiltrations, analgesics), with a frontal deformity \< 10° for a primary implantation * Written informed consent by the patient * Patients affiliated to the French social security system Exclusion Criteria: * Knee deformity \> 10 * Obesity (BMI \> 30) * Inflammatory rheumatism * History of infection * Poor skin coverage at the knee joint * Known allergy to the materials used and/or anesthetic used in the surgery * Repeated falls, major neurological disorders, mental or neuromuscular disorders which can be a source of post-operative complications * Significant functional deficit of the collateral ligaments * Positive serum or urine pregnancy test for woman with child bearing potential. Pregnancy or within 48 hours post-partum or breast feeding women * Phobic patient refusing to have an MRI * Patient with a contraindication to have an MRI (active medical devices, metal implants, etc.) * Patient under legal protection * Patient participating in another Clinical Investigation * Post fracture osteoarthritis * Osteoporosis * Anatomical configuration not allowing the implant to be fixed (depending on size constraints) * Disabling comorbidity upon any resumption of physical activity
Where this trial is running
Paris
- Hôpital Lariboisière — Paris, France (Recruiting)
Study contacts
- Principal investigator: Pascal BIZOT, MD, Pr — Aphp
- Study coordinator: Pascal BIZOT, MD, Pr
- Email: pascal.bizot@aphp.fr
- Phone: +33 (0)1 49 95 91 34
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.