Fibular Fixation in Ankle Fractures:Plate Verses Nail.

Not Applicable

Completed

• Conditions: Distal Fibula Fracture

• Registration Number: NCT02507193
• Lead Sponsor: Orlando Health, Inc.

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.

Study Timeline

• Study First Submitted: 2015-06-03
• Study Start: 2015-07
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Status Verified: 2018-10
• Primary Completion: 2019-08-15
• Study Completion: 2019-08-15
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

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

Exclusion Criteria

• Weber A distal fibula fractures
• Pathologic fractures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional outcome using the Olerud-Molander score.	One year.	The Olerud-Molander score is as assessment of symptoms after ankle fracture.

Trial Locations

Locations (1)

Orlando Health; 🇺🇸 Orlando, Florida, United States