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

NCT03163017 | Completed Results FDA Device

• 1 other identifier: HSC-MS-16-0840
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

3D Fluoroscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately at the time of 3D Fluoroscopy

Secondary Outcomes (12)

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

  Immediately at the time of 3D Fluoroscopy

• Pain as Assessed by the AOFAS Score

  3 months after 3D Fluoroscopy

• Function as Assessed by the AOFAS Score

  3 months after 3D Fluoroscopy

• Alignment as Assessed by the AOFAS Score

  3 months after 3D Fluoroscopy

• Pain as Assessed by the AOFAS Score

  6 months after 3D Fluoroscopy

Study Arms (1)

2D Fluoroscopy then 3D Fluoroscopy

EXPERIMENTAL

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".

Device: 2D Fluoroscopy; Device: 3D Fluoroscopy

Interventions

2D Fluoroscopy 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.

2D Fluoroscopy then 3D Fluoroscopy

3D Fluoroscopy 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.

2D Fluoroscopy then 3D Fluoroscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Skeletally mature
• Patients with unilateral, acute, displaced ankle fractures with preoperative evidence of syndesmotic disruption or intraoperative evidence of syndesmotic instability following malleolar fixation.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• AO Trauma North America: collaborator

Study Sites (1)

The University of Texas at Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Results Point of Contact

• Title: Joshua Gary, MD
• Organization: The University of Texas Health Science Center at Houston

Joshua.L.Gary@uth.tmc.edu

713-486-6500

Study Officials

• Joshua L Gary, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 22, 2017
• Study Start: March 1, 2017
• Primary Completion: September 11, 2018
• Study Completion: September 11, 2018
• Last Updated: September 12, 2019
• Results First Posted: September 12, 2019

Record last verified: 2019-08

Locations

US (1)