Fibular Fixation in Ankle Fractures:Plate Verses Nail.

Distal Fibula Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507193
• Other study ID #: 15.037.04.
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: August 15, 2019

Study information

• Verified date: October 2018
• Source: Orlando Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Distal fibula fracture

• Pilon fractures

• Open fractures

• Ipsilateral foot

Exclusion Criteria:

• Weber A distal fibula fractures

• Pathologic fractures

Related Conditions & MeSH terms

• Ankle Fractures
• Distal Fibula Fracture
• Fractures, Bone

Intervention

Procedure:
• Open reduction internal fixation
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 Nail
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.

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Orlando Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome using the Olerud-Molander score.	The Olerud-Molander score is as assessment of symptoms after ankle fracture.	One year.