Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-01-26 @ 1:59 AM
Study NCT ID:
NCT02032966
Status:
UNKNOWN
Last Update Posted:
2018-11-28
First Post:
2014-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Versus Nonsurgical Treatment of Fibular Fractures: A Prospective Randomized Study
Sponsor:
University of Tennessee
Organization:
Study Overview
Official Title:
Outcomes Following Surgical Versus Nonsurgical Treatment of Fibular Fractures Following Operative Fixation of Unstable Medial Malleolus Fractures: A Prospective Randomized Study
Status:
UNKNOWN
Status Verified Date:
2018-11
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:
Isolated surgical repair of the inside portion of the tibia may be enough to stabilize an ankle fracture in which both the tibia and the fibula are broken. This would alleviate the need for another incision, plate, and screws to repair the fibula. The purpose of this study is to help determine if surgically repairing only the tibia fracture will lead to equivalent clinical outcomes when compared with surgical repair of both bones.
The hypothesis of this study is that operative stabilization of the medial malleolus fracture only, in otherwise ligamentously stable bimalleolar and/or trimalleolar fractures of the ankle, will lead to equivalent clinical outcomes and functional scores as those treated with operative stabilization of both malleoli and/or all malleoli.
The hypothesis of this study is that operative stabilization of the medial malleolus fracture only, in otherwise ligamentously stable bimalleolar and/or trimalleolar fractures of the ankle, will lead to equivalent clinical outcomes and functional scores as those treated with operative stabilization of both malleoli and/or all malleoli.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: