Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592248
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Evaluation of a New Bi-Condylar Total Knee Prosthesis TKP with All-Ceramic Friction The Forgotten Knee
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of a New Bi-Condylar Total Knee Prosthesis TKP with All-Ceramic Friction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ForgottenKne
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None