Ignite Creation Date:
2024-05-06 @ 9:49 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03081260
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2017-03-09
Brief Title:
Long-term Evaluation Protocol 12 Months Postoperative of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Long-term Evaluation Protocol 12 Months Postoperative of Total Knee Prostheses Anatomic With Resurfaced Patella Versus Non-resurfaced Patella in Patients Requiring Total Knee Arthroplasty Prospective Monocentric Randomized Open-label Study
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Total knee arthroplasty is a frequent surgery in France It currently represents 70000 interventions per year The total knee prosthesis is also called tri-compartmental because it allows articulation between the femur and the tibia but also between the femur and the patella
The patella belongs to the extensor system It articulates with the femoral trochlea in which it slides It has an important biomechanical role on the quadriceps strength in addition to allowing flexion-extension movements
In the case of resurfacing the joint face of the patella is cut off A convex polyethylene implant is sealed with cement using studs on the same face
In case of non-resurfacing the surgeon leaves in place the cartilage of the patella which will be in direct contact with the femoral prosthetic trochlea
Both methods have advantages and disadvantages For some implants it is recommended to resurface the patella because the implant is not very tolerant with the native patella Other implants have been designed to be better adapted to the preservation of patellar cartilage
There is currently no evidence that one method is superior to the other on new generation implants known as patellar friendly
It seems necessary to compare both methods in terms of long-term postsurgery results
The patella belongs to the extensor system It articulates with the femoral trochlea in which it slides It has an important biomechanical role on the quadriceps strength in addition to allowing flexion-extension movements
In the case of resurfacing the joint face of the patella is cut off A convex polyethylene implant is sealed with cement using studs on the same face
In case of non-resurfacing the surgeon leaves in place the cartilage of the patella which will be in direct contact with the femoral prosthetic trochlea
Both methods have advantages and disadvantages For some implants it is recommended to resurface the patella because the implant is not very tolerant with the native patella Other implants have been designed to be better adapted to the preservation of patellar cartilage
There is currently no evidence that one method is superior to the other on new generation implants known as patellar friendly
It seems necessary to compare both methods in terms of long-term postsurgery results
Detailed Description:
The analysis of the primary endpoint International Knee Society score IKS score will be based on the assumption that the postsurgery score will be identical in both groups The t test for independent samples will be used to test this hypothesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-A01697-44 | OTHER | ANSM | None |