Fibular Fixation in Ankle Fractures:Plate Verses Nail.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-08-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Distal Fibula Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Open reduction internal fixation(ORIF)

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.

Group Type ACTIVE_COMPARATOR

Open reduction internal fixation

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Intermedullary Nail

Intervention Type PROCEDURE

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

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE