Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04872855
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-30
First Post:
2021-04-26
Brief Title:
Observational Study to Evaluate Clinical Performance and Safety in Total Knee Arthroplasty
Sponsor:
Corin
Organization:
Corin
Study Overview
Official Title:
Observational Study to Evaluate the Performance and the Safety of the HLS KneeTec Cementless or Hybrid Fixations in Total Knee Arthroplasty
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
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:
The aim of this study is to assess the long-term performance and safety of HLS KneeTec cementless and hybrid fixation knee prosthesis when used in standard medical practice
Detailed Description:
It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in French sites where Total Knee Arthroplasty with HLS Kneetec cementless and hybrid fixation knee prosthesis is performed routinely
All patients treated with HLS KneeTec cementless or hybrid versions implant will be included All eligible patients seen in consultation and who agree to participate in the study should be included systematically and consecutively since the initiation of the study
Patients will be assessed according to the usual practice of the investigator at each participating site before surgery and then at the follow-up FU visits as following 4 months - 2 months 1 year - 2 months 5 years - 12 months and 10 years - 12 months
All patients treated with HLS KneeTec cementless or hybrid versions implant will be included All eligible patients seen in consultation and who agree to participate in the study should be included systematically and consecutively since the initiation of the study
Patients will be assessed according to the usual practice of the investigator at each participating site before surgery and then at the follow-up FU visits as following 4 months - 2 months 1 year - 2 months 5 years - 12 months and 10 years - 12 months
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