Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-02 @ 3:39 AM
Study NCT ID:
NCT04063657
Status:
TERMINATED
Last Update Posted:
2022-02-09
First Post:
2019-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
External Fixation Versus Splinting of Acute Calcaneus Fractures
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
External Fixation Versus Splinting of Acute Calcaneus Fractures Prior to Definitive Surgery
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was slow to recruit. PI decided to close study to focus on other trials.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim:
* Determine if external fixation decreases soft tissue complications compared to splinting.
* Determine if external fixation decreases time to definitive surgical stabilization and improves final fixation compared to splinting.
* Determine if external fixation improves functional outcomes as evaluated by validated functional scoring systems.
Hypothesis:
* External fixation improves definitive fixation and functional outcomes of acute calcaneal fractures with decreased complication rates compared to splinting
* Determine if external fixation decreases soft tissue complications compared to splinting.
* Determine if external fixation decreases time to definitive surgical stabilization and improves final fixation compared to splinting.
* Determine if external fixation improves functional outcomes as evaluated by validated functional scoring systems.
Hypothesis:
* External fixation improves definitive fixation and functional outcomes of acute calcaneal fractures with decreased complication rates compared to splinting
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: