Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-27 @ 7:06 AM
Study NCT ID:
NCT04727060
Status:
TERMINATED
Last Update Posted:
2024-07-16
First Post:
2020-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty
Sponsor:
Corin
Organization:
Study Overview
Official Title:
A Prospective and Retrospective, Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty Using HLS Implants
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the clinical data collected to date are sufficient for regulatory requirements
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.
Detailed Description:
It is planned to collect prospective and retrospective data from a continuous and exhaustive series of patients in a French center where Total Knee Arthroplasty with HLS prosthesis is performed routinely.
All patients treated with HLS KneeTec (cemented, non-cemented 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.
Data will be collected retrospectively for HLS I, II, Evolution and Noetos® implants, and when prospectively for cementless, cemented and hybrid HLS KneeTec prosthesis.
Post-surgery visit data will be collected at 1-y , 3-y , 5-y, 10-y FU visits per protocol then up to the latest FU visit available.
All patients treated with HLS KneeTec (cemented, non-cemented 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.
Data will be collected retrospectively for HLS I, II, Evolution and Noetos® implants, and when prospectively for cementless, cemented and hybrid HLS KneeTec prosthesis.
Post-surgery visit data will be collected at 1-y , 3-y , 5-y, 10-y FU visits per protocol then up to the latest FU visit available.
Study Oversight
Has Oversight DMC:
False
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?: