Fibular Fixation in Ankle Fractures:Plate Verses Nail.

Orlando Health, Inc.

Status: Completed

Conditions: Distal Fibula Fracture

Treatments: Procedure: Intermedullary Nail; Procedure: Open reduction internal fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT02507193

15.037.04.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Weber A distal fibula fractures
• Pathologic fractures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

Open reduction internal fixation(ORIF)

Active Comparator group

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.

Treatment:

Procedure: Open reduction internal fixation

Intermedullary (IM) Nail

Active Comparator group

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.

Treatment:

Procedure: Intermedullary Nail