Ignite Creation Date:
2024-05-06 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089525
Status:
RECRUITING
Last Update Posted:
2023-10-18
First Post:
2023-09-13
Brief Title:
Treatment of Complex Pilon Fractures
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Treatment of Complex Pilon Fractures A Pilot Study Comparing Primary Arthrodesis PA to Open Reduction and Internal Fixation ORIF
Status:
RECRUITING
Status Verified Date:
2023-10
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:
None
Brief Summary:
This project intends to compare patient outcomes between patients undergoing ORIF compared to PA or ankle fusion following an acute pilon fracture Limited literature comparing ORIF and ankle fusion as a primary procedure exists Particularly no present literature exists examining the novel arthrodesis surgical technique utilized in this study in conjunction with Opal sensor gait analysis data This study will serve as a pilot study and assess patient gait degree of pain functional outcome scores development of post-traumatic arthritis andor infection need for secondary surgery and return to work time
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