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

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Knee Osteoarthritis

Treatments

Device: Coc Knee

Study type

Interventional

Funder types

Other

Identifiers

NCT06592248

APHP190284

2020-A02892-37 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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