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

Not Applicable

Completed

• Conditions: Displaced Ankle Fractures

• Registration Number: NCT03163017
• Lead Sponsor: The University of Texas Health Science Center, Houston

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-19
• Study First Posted: 2017-05-22
• Primary Completion: 2018-09-11
• Study Completion: 2018-09-11
• Status Verified: 2019-08
• Results First Submitted: 2019-08-22
• Results First Submitted QC: 2019-08-22
• Last Update Submitted: 2019-08-22
• Results First Posted: 2019-09-12
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy	Immediately at the time of 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Texas at Health Science Center at Houston; 🇺🇸 Houston, Texas, United States