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

NCT ID: NCT03163017

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2018-09-11

Brief Summary

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.

Conditions

Displaced Ankle Fractures

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2D Fluoroscopy then 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 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".

Group Type: EXPERIMENTAL

2D Fluoroscopy

Intervention Type: DEVICE

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 Fluoroscopy

Intervention Type: DEVICE

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.

Interventions

2D 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 et al i.e. 2D Fluoroscopy using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system.

Intervention Type: DEVICE

3D Fluoroscopy

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Trauma North America

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Joshua L Gary

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua L Gary, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas at Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HSC-MS-16-0840

Identifier Type: -

Identifier Source: org_study_id