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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Implementation of a ceramic on ceramic knee prosthesis
Hôpital Lariboisière
Paris, France
RECRUITINGEvaluation of clinical endpoint 1(Oxford score) at 12 months
Clinical 1 : Oxford functional score : 12 (good) to 60 (bad) 12 questions (1 normal to 5 discomfort )
Time frame: 1 year
Evaluation of clinical endpoint 2 (IKS score) at 12 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
Time frame: 1 year
Evaluation of clinical endpoint 3 (Forgotten Joint score) at 12 months
Clinical 3 : Forgotten Joint Score (FJS) : 12 questions (0 normal to 4 discomfort ) = Total then FJScore = 100 - (Total x 25)
Time frame: 1 year
Evaluation of clinical endpoint 4 (Joint sounds) at 12 months
Clinical 4: Joint sounds : 5 questions, no score
Time frame: 1 year
Evaluation of clinical endpoint 5 (Pain) at 12 months
Clinical 5: Pain : 0 to 6
Time frame: 1 year
Evaluation of clinical endpoint 6 (Knee mobility) at 12 months
Clinical 6: Knee mobility : Flexion (°) Extension (°)
Time frame: 1 year
Evaluation of clinical endpoint 7 (Knee stability) at 12 months
Clinical 7: Knee stability : Frontal (° and mm) Sagittal (° and mm)
Time frame: 1 year
Evaluation of radiographic endpoints at 12 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.
Time frame: 1 year
Evaluation of clinical endpoint 1 (Oxford score) at 3 and 6 months and physical capabilities of the patient
Clinical 1 : Oxford functional score : 12 (good) to 60 (bad) 12 questions (1 normal to 5 discomfort )
Time frame: 3 and 6 months
Evaluation of clinical endpoint 2 (IKS score) at 3 and 6 months and physical capabilities of the patient
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
Time frame: 3 and 6 months
Evaluation of clinical endpoint 3 (FJ Score) at 3 and 6 months and physical capabilities of the patient
Clinical 3 : Forgotten Joint Score (FJS) : 12 questions (0 normal to 4 discomfort ) = Total then FJScore = 100 - (Total x 25)
Time frame: 3 and 6 months
Evaluation of clinical endpoint 4 (Joint sounds) at 3 and 6 months and physical capabilities of the patient
Clinical 4 : Joint sounds : 5 questions, no score
Time frame: 3 and 6 months
Evaluation of clinical endpoint 5 (Pain) at 3 and 6 months and physical capabilities of the patient
Clinical 5 : Pain : 0 to 6
Time frame: 3 and 6 months
Evaluation of clinical endpoint 6 (Knee mobility) at 3 and 6 months and physical capabilities of the patient
Clinical 6 : Knee mobility : Flexion (°) Extension (°)
Time frame: 3 and 6 months
Evaluation of clinical endpoint 7 (Knee stability) at 3 and 6 months and physical capabilities of the patient
Clinical 7 : Knee stability : Frontal (° and mm) Sagittal (° and mm)
Time frame: 3 and 6 months
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Evaluation of radiographic endpoints at 3 and 6 months and physical capabilities of the patient
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.
Time frame: 3 and 6 months
Evaluation of fibrous tissue
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.
Time frame: 1 year
Validation of the ancillary equipment used and the prosthesis surgical technique
Notification of any malfunction noticed during the use of ancillary equipment
Time frame: 1 year