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Fibular Fixation in Ankle Fractures:Plate Verses Nail.

Primary Purpose

Distal Fibula Fracture

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open reduction internal fixation
Intermedullary Nail
Sponsored by
Orlando Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Fibula Fracture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Distal fibula fracture
  • Pilon fractures
  • Open fractures
  • Ipsilateral foot

Exclusion Criteria:

  • Weber A distal fibula fractures
  • Pathologic fractures

Sites / Locations

  • Orlando Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Open reduction internal fixation(ORIF)

Intermedullary (IM) Nail

Arm Description

This 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.

This 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.

Outcomes

Primary Outcome Measures

Functional outcome using the Olerud-Molander score.
The Olerud-Molander score is as assessment of symptoms after ankle fracture.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2015
Last Updated
August 27, 2019
Sponsor
Orlando Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02507193
Brief Title
Fibular Fixation in Ankle Fractures:Plate Verses Nail.
Official Title
Fibular Fixation in Ankle Fractures: a Randomized-Controlled Trial Comparing Plating Versus Intramedullary Nailing
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orlando Health, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. This objective will be accomplished using the Olerud-Molander score, a commonly accepted functional outcome score used to evaluate patients post-operatively who have undergone foot and ankle procedures. It is a survey that evaluates patient reported outcomes including pain, stiffness, swelling, stair climbing, running, jumping, squatting, use of supports, and work/activities of daily living (ADL) level. It does not involve physician-measured outcomes. The best possible score is a total of 100. Patients will be given a form to complete throughout follow-up and be utilized for data analysis. Functional outcome will be analyzed with regards to type of fracture, gender, cause of fracture, and affected side to determine if these factors are responsible for any difference.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Fibula Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open reduction internal fixation(ORIF)
Arm Type
Active Comparator
Arm Description
This 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.
Arm Title
Intermedullary (IM) Nail
Arm Type
Active Comparator
Arm Description
This 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.
Intervention Type
Procedure
Intervention Name(s)
Open reduction internal fixation
Other Intervention Name(s)
ORIF
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intermedullary Nail
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional outcome using the Olerud-Molander score.
Description
The Olerud-Molander score is as assessment of symptoms after ankle fracture.
Time Frame
One year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Distal fibula fracture Pilon fractures Open fractures Ipsilateral foot Exclusion Criteria: Weber A distal fibula fractures Pathologic fractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth J. Koval, MD
Organizational Affiliation
Orlando Health
Official's Role
Study Director
Facility Information:
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States

12. IPD Sharing Statement

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Fibular Fixation in Ankle Fractures:Plate Verses Nail.

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