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

Does Intraoperative 3D Fluoroscopy Accurately Assess Syndesmotic Reduction Following Traumatic Ankle Injury?

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 Overview

• Status: Completed
• Conditions: Displaced Ankle Fractures
• Intervention / Treatment: Device: 2D Fluoroscopy; Device: 3D Fluoroscopy

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas at Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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".

Device: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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	3 months after 3D Fluoroscopy
Pain as Assessed by the AOFAS Score	The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores	6 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	6 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	6 months after 3D Fluoroscopy
Pain as Assessed by the PROMIS Score	Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures	3 months after 3D Fluoroscopy
Function as Assessed by the PROMIS Score	Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures	3 months after 3D Fluoroscopy
Pain as Assessed by the PROMIS Score	Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures	6 months after 3D Fluoroscopy
Function as Assessed by the PROMIS Score	Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures	6 months after 3D Fluoroscopy
Number of Participants With Syndesmotic Malreduction as Assessed by a Single Postoperative Bilateral CT Scan	Malreduction will be determined by comparing uninjured ankle to the injured ankle	1 day after 3D Fluoroscopy

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: AO Trauma North America
• Investigators: Principal Investigator: Joshua L Gary, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): September 11, 2018
• Study Completion (Actual): September 11, 2018

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: August 22, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: 3D Fluoroscopy
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: HSC-MS-16-0840

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No