Fibular Fixation in Ankle Fractures:Plate Verses Nail.
1 other identifier
interventional
51
1 country
1
Brief Summary
The primary objective of this study will be to evaluate the functional outcome of patients who present with a distal fibula fracture who were treated with either intermedullary nail (IMN) fixation or plate fixation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedFirst Posted
Study publicly available on registry
July 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2019
CompletedAugust 28, 2019
October 1, 2018
4.1 years
June 3, 2015
August 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Functional outcome using the Olerud-Molander score.
The Olerud-Molander score is as assessment of symptoms after ankle fracture.
One year.
Study Arms (2)
Open reduction internal fixation(ORIF)
ACTIVE COMPARATORThis surgical intervention is performed using a plate and screws.Under general anesthesia, an incision is made at the site of the break or injury, and the fracture is carefully re-aligned . The plate and screws are installed, and the incision is closed with staples or stitches. Synthes and Stryker plate and screws will be used.
Intermedullary (IM) Nail
ACTIVE COMPARATORThis surgical intervention is performed using an intermedullary nail. Under general anesthesia, an incision is made at the site of the break or injury, and the fracture is carefully reduced. The nail in inserted through the medullary canal after proper imaging for accurate placement. The incision is closed with staples or stitches. Acumed fibula nail will be used.
Interventions
An incision is made at the site of the break or injury, and the fracture is carefully re-aligned . The plate and screws are installed, and the incision is closed with staples or stitches. Synthes and Stryker plate and screws will be used.
An incision is made at the site of the break or injury, and the fracture is carefully reduced. The nail in inserted through the medullary canal after proper imaging for accurate placement. The incision is closed with staples or stitches. Acumed fibula nail will be used.
Eligibility Criteria
You may qualify if:
- Distal fibula fracture
- Pilon fractures
- Open fractures
- Ipsilateral foot
You may not qualify if:
- Weber A distal fibula fractures
- Pathologic fractures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orlando Health
Orlando, Florida, 32806, United States
Study Officials
- STUDY DIRECTOR
Kenneth J. Koval, MD
Orlando Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Research Coordinator
Study Record Dates
First Submitted
June 3, 2015
First Posted
July 23, 2015
Study Start
July 1, 2015
Primary Completion
August 15, 2019
Study Completion
August 15, 2019
Last Updated
August 28, 2019
Record last verified: 2018-10