Ignite Creation Date:
2024-05-06 @ 3:47 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02374944
Status:
RECRUITING
Last Update Posted:
2022-11-09
First Post:
2015-02-10
Brief Title:
Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
A Randomized Clinical Trial Evaluating Fixation Insitu Versus Removal for Midfoot Lisfranc Injuries
Status:
RECRUITING
Status Verified Date:
2022-11
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:
FIRM
Brief Summary:
This study is a multicenter prospective randomized control trial comparing hardware retention HR to removal of hardware RH
Detailed Description:
Eligible patients will be randomized to one of two treatment arms Hardware removal at 6 months or Hardware retention for a minimum of 2 years
Consenting patients having previously undergone open reduction and internal fixation of Lisfranc injuries with an anatomic reconstruction within 6-8 weeks will be randomized to one of two treatment arms removal hardware RH or hardware retention HR
Outcome will be assessed at 6 weeks 12 weeks 6 months 1 year and 2 years from enrollment
Consenting patients having previously undergone open reduction and internal fixation of Lisfranc injuries with an anatomic reconstruction within 6-8 weeks will be randomized to one of two treatment arms removal hardware RH or hardware retention HR
Outcome will be assessed at 6 weeks 12 weeks 6 months 1 year and 2 years from enrollment
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