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

The University of Texas System (UT)

Status: Completed

Conditions: Displaced Ankle Fractures

Treatments: Device: 2D Fluoroscopy; Device: 3D Fluoroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03163017

HSC-MS-16-0840

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

2D Fluoroscopy then 3D Fluoroscopy

Experimental group

Description:

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

Treatment:

Device: 2D Fluoroscopy

Device: 3D Fluoroscopy