Status:
RECRUITING
Evaluation of a New Bi-Condylar Total Knee Prosthesis (TKP) With All-Ceramic Friction (The Forgotten Knee)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The results of TKP (Total Knee Prosthesis) are satisfactory but do not reach those of THP (Total Hip Prosthesis) in terms of indolence and function. By using an all-ceramic friction torque, identical ...
Detailed Description
The aim of this study is to evaluate the all-ceramic knee prosthesis, according to clinical and radiological criteria of usual follow-up of a TKP for knee osteoarthritis, at 12 months. Evaluation of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 19 2026
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06592248
Start Date
December 19 2024
End Date
December 19 2026
Last Update
January 15 2025
Active Locations (1)
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1
Hôpital Lariboisière
Paris, France, 75010