Assessment of Ability of 3D Fluorscopy in Aiding Accurate Syndesmotic Reduction Following Traumatic Ankle Injury

The University of Texas Health Science Center, Houston30 enrolled

Overview

The purpose of this study is to determine if use of new imaging technology termed "3D fluoroscopy" will lead the surgeon to change the position of the fractured bones to a more accurate position.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Displaced Ankle Fractures

Interventions

2D FluoroscopyDEVICE

Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers et al i.e. 2D Fluoroscopy using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system.

3D FluoroscopyDEVICE

After the attending surgeon is satisfied with the reduction quality from 2D Fluoroscopy, 3D fluoroscopy using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system will be used to generate additional images to assess syndesmotic and fibular reductions.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Skeletally mature * Patients with unilateral, acute, displaced ankle fractures with preoperative evidence of syndesmotic disruption or intraoperative evidence of syndesmotic instability following malleolar fixation. Exclusion Criteria: * Patients skeletally immature; * Patients less than age 18 years and more than age 75; * Patients with previous ankle trauma to either ankle; * Patients with bilateral ankle injuries; * Patients with previous osseous injuries to the tibia or fibula; and * Patients with isolated syndesmotic injury and no fracture (i.e. high ankle sprains)

Locations (1)

The University of Texas at Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy

Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess syndesmotic reductions.

Time frame: Immediately at the time of 3D Fluoroscopy

Secondary Outcomes

Number of Participants for Which the Surgeon Changed Reduction of Fibular Fracture Reduction Because of Information Provided by 3D Fluoroscopy

Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess fibular fracture reductions.

Time frame: Immediately at the time of 3D Fluoroscopy

Pain as Assessed by the AOFAS Score

The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores

Time frame: 3 months after 3D Fluoroscopy

Function as Assessed by the AOFAS Score

The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores

Time frame: 3 months after 3D Fluoroscopy

Alignment as Assessed by the AOFAS Score

The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores

Data from ClinicalTrials.gov

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