Taking peopleNo phase

Evaluation of a New Bi-Condylar Total Knee Prosthesis (TKP) With All-Ceramic Friction (The Forgotten Knee)

Key facts

Who runs it: Assistance Publique - Hôpitaux de Paris
Where: France1 site in 1 countryChoose a country to see its sites
Trial code: NCT06592248
Status: Recruiting
People taking part: 5 people, planned
Started: 19 Dec 2024
Expected to end: 19 Dec 2026
Type of study: Interventional
Treatments tested: Coc Knee
Record updated: 15 January 2025

Who can take part

Age: 18 years to 70 years
Sex: Women and men
Healthy volunteers: Cannot take part

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

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

Who cannot take part

Patient with a contraindication to have an MRI (active medical devices, metal implants, etc.)
Anatomical configuration not allowing the implant to be fixed (depending on size constraints)
History of infection
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
Positive serum or urine pregnancy test for woman with child bearing potential. Pregnancy or within 48 hours post-partum or breast feeding women
Knee deformity > 10
Obesity (BMI > 30)
Inflammatory rheumatism
Poor skin coverage at the knee joint
Significant functional deficit of the collateral ligaments
Phobic patient refusing to have an MRI
Patient under legal protection
Patient participating in another Clinical Investigation
Post fracture osteoarthritis
Osteoporosis
Disabling comorbidity upon any resumption of physical activity

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 70 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.