Ignite Creation Date:
2024-10-25 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638138
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Study of Artelon FLEXBAND for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament ATFL to Treat Lateral Ankle Instability
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-center Prospective Blinded Randomized Study of Artelon FLEXBAND for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament ATFL to Treat Lateral Ankle Instability
Status:
ENROLLING_BY_INVITATION
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:
The goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified Bröstrom reconstruction procedure for repair of the ATFL Study participants undergoing ATFL reconstructive procedure using the ARTELON FLEXBAND System as an augmentation device will be compared to study participants undergoing a standard modified Bröstrom procedure alone Clinician reported safety and functional outcomes measures will be collected at baseline and at 2- 6- 12- 18 and 26-weeks and 1- and 2-years post-surgery
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