Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04692714
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2020-12-30
Brief Title:
Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses Stryker Cemented Versus Uncemented
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses Stryker Cemented Versus Uncemented Prospective Randomized Single-center Multisite Non-inferiority Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
MAKO CIMENT
Brief Summary:
Total knee replacement surgery TKA is a treatment for advanced tibial-femoral osteoarthritis This intervention is justified in case of significant discomfort and failure of medical treatment It aims to replace the native internal and external femoro-tibial joints with a joint between a femoral implant and a tibial implant
Implants can be cemented or cementless The longevity of these implants depends among other things on the quality of the bone fixation of the implants It is therefore essential that this fixation be evaluated The advantages of an uncemented TKA are the preservation of bone stock the absence of wear by cement debris and prolonged fixation thanks to osseointegration These characteristics are all the more interesting in a young population
Numerous studies have been carried out on the survival of TKA with and without cement The results found are not unanimous and mainly concern the survival of the implants and the presence of radiological signs of loosening In addition no study has evaluated the results of TKA with or without cement implanted using robotic assistance The precision provided by the robotic system could improve the results of these uncemented implants
Very few studies are interested in the functional results according to the cementation or not of TKA And most of these studies do not have a high level of methodological evidence
We would like to prospectively evaluate the functional results survival as well as the rate of radiological border after TKA with or without cement posed with robotic assistance in the short and medium term
Implants can be cemented or cementless The longevity of these implants depends among other things on the quality of the bone fixation of the implants It is therefore essential that this fixation be evaluated The advantages of an uncemented TKA are the preservation of bone stock the absence of wear by cement debris and prolonged fixation thanks to osseointegration These characteristics are all the more interesting in a young population
Numerous studies have been carried out on the survival of TKA with and without cement The results found are not unanimous and mainly concern the survival of the implants and the presence of radiological signs of loosening In addition no study has evaluated the results of TKA with or without cement implanted using robotic assistance The precision provided by the robotic system could improve the results of these uncemented implants
Very few studies are interested in the functional results according to the cementation or not of TKA And most of these studies do not have a high level of methodological evidence
We would like to prospectively evaluate the functional results survival as well as the rate of radiological border after TKA with or without cement posed with robotic assistance in the short and medium term
Detailed Description:
None
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