Evaluation of a New Bi-Condylar Total Knee Prosthesis (TKP) With All-Ceramic Friction (The Forgotten Knee)
Evaluation of a New Bi-Condylar Total Knee Prosthesis (TKP) With All-Ceramic Friction
Assistance Publique - Hôpitaux de Paris
5 participants
Dec 19, 2024
INTERVENTIONAL
Conditions
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 to that of the hip, the promotor of this Clinical Investigation expects to obtain an improvement in term of indolence, ability to perform heavy activities, knee stability and an improvement in the long-term survival of TKP, while at the same time, a decrease in the rate of re-intervention in young patients.
Eligibility
Inclusion Criteria3
- 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 Criteria17
- 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
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Interventions
Implementation of a ceramic on ceramic knee prosthesis
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06592248