Knee Osteoarthritis
Conditions
Keywords
Total Knee Prosthesis, Ceramic on ceramic bearing
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 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.
Interventions
DEVICECoc Knee
Implementation of a ceramic on ceramic knee prosthesis
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
* Validation of the concept * Absence of added risks after implementation * Measurement of fibrous tissue formed by MRI examination Inclusion will be done by sequencing in 2 steps: * Inclusion of 2 patients with implementation of the experimental MD with a post-operative follow-up of 3 months, * if no SAE linked to the experimental MD is detected, the inclusions will continue until the 5th patient with experimental DM, * In the event of notification of an SAE linked to the experimental MD according to the investigator in the first 2 patients, within the first 3 months, the research will be stopped prematurely
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of clinical endpoint 1(Oxford score) at 12 months | 1 year | Clinical 1 : Oxford functional score : 12 (good) to 60 (bad) 12 questions (1 normal to 5 discomfort ) |
| Evaluation of clinical endpoint 2 (IKS score) at 12 months | 1 year | Clinical 2 : International Knee Society (IKS) score : * objective component (symptoms) 25 points * subjective component: * expectation (pre or post surgery) 15 points * satisfaction 40 points * function 100 points |
| Evaluation of clinical endpoint 3 (Forgotten Joint score) at 12 months | 1 year | Clinical 3 : Forgotten Joint Score (FJS) : 12 questions (0 normal to 4 discomfort ) = Total then FJScore = 100 - (Total x 25) |
| Evaluation of clinical endpoint 4 (Joint sounds) at 12 months | 1 year | Clinical 4: Joint sounds : 5 questions, no score |
| Evaluation of clinical endpoint 5 (Pain) at 12 months | 1 year | Clinical 5: Pain : 0 to 6 |
| Evaluation of clinical endpoint 6 (Knee mobility) at 12 months | 1 year | Clinical 6: Knee mobility : Flexion (°) Extension (°) |
| Evaluation of clinical endpoint 7 (Knee stability) at 12 months | 1 year | Clinical 7: Knee stability : Frontal (° and mm) Sagittal (° and mm) |
| Evaluation of radiographic endpoints at 12 months | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of fibrous tissue | 1 year | Evaluation of fibrous tissue around the prosthesis: Performance of ultrasounds and MRI at 3, 6 and 12 months postoperatively, allowing to evaluate and measure (in mm) the thickness and progression of fibrous tissue around the prosthesis. |
| Evaluation of clinical endpoint 1 (Oxford score) at 3 and 6 months and physical capabilities of the patient | 3 and 6 months | Clinical 1 : Oxford functional score : 12 (good) to 60 (bad) 12 questions (1 normal to 5 discomfort ) |
| Validation of the ancillary equipment used and the prosthesis surgical technique | 1 year | Notification of any malfunction noticed during the use of ancillary equipment |
| Evaluation of clinical endpoint 2 (IKS score) at 3 and 6 months and physical capabilities of the patient | 3 and 6 months | Clinical 2 : International Knee Society (IKS) score : * objective component (symptoms) 25 points * subjective component: * expectation (pre or post surgery) 15 points * satisfaction 40 points * function 100 points |
| Evaluation of clinical endpoint 3 (FJ Score) at 3 and 6 months and physical capabilities of the patient | 3 and 6 months | Clinical 3 : Forgotten Joint Score (FJS) : 12 questions (0 normal to 4 discomfort ) = Total then FJScore = 100 - (Total x 25) |
| Evaluation of clinical endpoint 4 (Joint sounds) at 3 and 6 months and physical capabilities of the patient | 3 and 6 months | Clinical 4 : Joint sounds : 5 questions, no score |
| Evaluation of clinical endpoint 5 (Pain) at 3 and 6 months and physical capabilities of the patient | 3 and 6 months | Clinical 5 : Pain : 0 to 6 |
| Evaluation of clinical endpoint 6 (Knee mobility) at 3 and 6 months and physical capabilities of the patient | 3 and 6 months | Clinical 6 : Knee mobility : Flexion (°) Extension (°) |
| Evaluation of clinical endpoint 7 (Knee stability) at 3 and 6 months and physical capabilities of the patient | 3 and 6 months | Clinical 7 : Knee stability : Frontal (° and mm) Sagittal (° and mm) |
| Evaluation of radiographic endpoints at 3 and 6 months and physical capabilities of the patient | 3 and 6 months | 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. |
Countries
France
Contacts
Primary ContactPascal BIZOT, MD, Pr
Outcome results
None listed