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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02892-37 | Other Identifier | IDRCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CocKnee | Experimental | Implementation of CocKnee |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coc Knee | Device | Implementation of a ceramic on ceramic knee prosthesis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation 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 ) | 1 year |
| Evaluation of clinical endpoint 2 (IKS score) at 12 months | Clinical 2 : International Knee Society (IKS) score :
| 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) | 1 year |
| Evaluation of clinical endpoint 4 (Joint sounds) at 12 months | Clinical 4: Joint sounds : 5 questions, no score | 1 year |
| Evaluation of clinical endpoint 5 (Pain) at 12 months | Clinical 5: Pain : 0 to 6 | 1 year |
| Evaluation of clinical endpoint 6 (Knee mobility) at 12 months | Clinical 6: Knee mobility : Flexion (°) Extension (°) | 1 year |
| Evaluation of clinical endpoint 7 (Knee stability) at 12 months | Clinical 7: Knee stability : Frontal (° and mm) Sagittal (° and mm) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ) | 3 and 6 months |
| Evaluation of clinical endpoint 2 (IKS score) at 3 and 6 months and physical capabilities of the patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pascal BIZOT, MD, Pr | Contact | +33 (0)1 49 95 91 34 | pascal.bizot@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pascal BIZOT, MD, Pr | APHP | Principal Investigator |
| Laurent SEDEL, MD, Pr | CC/ Contact | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Lariboisière | Recruiting | Paris | 75010 | France |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Inclusion will be done by sequencing in 2 steps:
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| 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. | 1 year |
Clinical 2 : International Knee Society (IKS) score :
|
| 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) | 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 | 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 | 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 (°) | 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) | 3 and 6 months |
| 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. | 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. | 1 year |
| Validation of the ancillary equipment used and the prosthesis surgical technique | Notification of any malfunction noticed during the use of ancillary equipment | 1 year |
| D012216 |
| Rheumatic Diseases |