NCT06592248

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 clinical and radiographic endpoints at 12 months: \- Clinical: functional scores (Oxford and International Knee Society IKS), pain (from 0 to 6, better to worse outcome), knee mobility in flexion and extension (degrees), frontal and sagittal stability (in degrees and mm), joint sounds, Forgotten Joint Score (FJS). The scores are mostly qualitative and all of them will be globally evaluated by the investigator regarding to the patient status. -Radiographic: X-rays of the front and profile of the prosthesis, positioning of the implants (angle, axis), existence of borders (bone cement, prosthesis cement), presence of osteolysis or any notable element. MRI will be performed to evaluate the creation of a specific fibrous tissue around the joint that is expected with a ceramic on ceramic bearing.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Coc Knee	Implementation of a ceramic on ceramic knee prosthesis

Timeline

• Start date: 2024-12-19
• Primary completion: 2025-12-19
• Completion: 2026-12-19
• First posted: 2024-09-19
• Last updated: 2025-01-15

Locations

1 site across 1 country: France