Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571955
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
ACL Reconstruction with a New Generation of LARS Artificial Ligament
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Anterior Cruciate Ligament ACL Reconstruction with a New Generation of LARS Artificial Ligament
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This clinical investigation is intended to demonstrate the safety of the new generation of LARS ligaments and compare this new generation grafted ligament of artificial ligament to the LARS current artificial ligament non-grafted ligament which is CE marked since 1997 in case of ACL injury The new generation of LARS artificial ligament is expected to improve physiological response by enhancing fibroblast proliferation fibroblast organization and collagen type I III secretion This physiological response leads to a better osseo-integration of the ligaments Therefore the study is expected to demonstrate the investigational device safety and biomechanical improvements
Detailed Description:
Forty subjects over 40 years old with acute ACL injury will be included A follow-up program is planned over 1 year per subject days 7 15 30 60 90 180 365 based on physical therapy biological analysis and biomechanical measurements
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