Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490594
Status:
UNKNOWN
Last Update Posted:
2008-10-20
First Post:
2007-06-20
Brief Title:
SeriACL Device Trial for Anterior Cruciate Ligament ACL Reconstruction
Sponsor:
Serica Technologies Inc
Organization:
Serica Technologies Inc
Study Overview
Official Title:
A Multi-Center Open Study to Evaluate the SeriACL Device for Primary Anterior Cruciate Ligament Repair
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 SeriACL device was developed as an alternative to an autograft ie tissue that is taken from a patients own body or an allograft ie tissue that is taken from a cadaver for ACL reconstruction The SeriACL device is made of silk yarns knit and processed with SeriCoat surface treatment which makes it easier to wet the material The SeriACL device is designed to be a temporary support structure to replace the torn ACL and to stabilize the knee joint following surgical repair It is designed to use the bodys own healing process to regenerate the patients own new ligament tissue As the new tissue grows and the support structure is needed less over time the SeriACL device is bioresorbed ie broken down by the patients body The SeriACL device is designed to be installed with standard surgical techniques for ACL repair
This study is designed to test the safety of the SeriACL device in primary total ACL repair in patients with a torn ACL The study will evaluate whether repair of the ACL with the SeriACL device will return the knee to normal function and what if any side effects will occur
This study is designed to test the safety of the SeriACL device in primary total ACL repair in patients with a torn ACL The study will evaluate whether repair of the ACL with the SeriACL device will return the knee to normal function and what if any side effects will occur
Detailed Description:
None
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