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Clinical Trials/NCT02507193
NCT02507193
Completed
Not Applicable

Fibular Fixation in Ankle Fractures: a Randomized-Controlled Trial Comparing Plating Versus Intramedullary Nailing

Orlando Health, Inc.1 site in 1 country51 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Distal Fibula Fracture
Sponsor
Orlando Health, Inc.
Enrollment
51
Locations
1
Primary Endpoint
Functional outcome using the Olerud-Molander score.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
August 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paula J. Harriott

Clinical Research Coordinator

Orlando Health, Inc.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Weber A distal fibula fractures
  • Pathologic fractures

Outcomes

Primary Outcomes

Functional outcome using the Olerud-Molander score.

Time Frame: One year.

The Olerud-Molander score is as assessment of symptoms after ankle fracture.

Study Sites (1)

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