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

Primary Purpose

Displaced Ankle Fractures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2D Fluoroscopy
3D Fluoroscopy
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Displaced Ankle Fractures focused on measuring 3D Fluoroscopy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • The University of Texas at Health Science Center at Houston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

2D Fluoroscopy then 3D Fluoroscopy

Arm 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".

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Pain as Assessed by the AOFAS Score
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Function as Assessed by the AOFAS Score
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Alignment as Assessed by the AOFAS Score
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Pain as Assessed by the AOFAS Score
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Function as Assessed by the AOFAS Score
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Alignment as Assessed by the AOFAS Score
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Pain as Assessed by the PROMIS Score
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Function as Assessed by the PROMIS Score
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Pain as Assessed by the PROMIS Score
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Function as Assessed by the PROMIS Score
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
Malreduction will be determined by comparing uninjured ankle to the injured ankle

Full Information

First Posted
May 19, 2017
Last Updated
August 22, 2019
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
AO Trauma North America
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1. Study Identification

Unique Protocol Identification Number
NCT03163017
Brief Title
Assessment of Ability of 3D Fluorscopy in Aiding Accurate Syndesmotic Reduction Following Traumatic Ankle Injury
Official Title
Does Intraoperative 3D Fluoroscopy Accurately Assess Syndesmotic Reduction Following Traumatic Ankle Injury?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
September 11, 2018 (Actual)
Study Completion Date
September 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
AO Trauma North America

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Displaced Ankle Fractures
Keywords
3D Fluoroscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2D Fluoroscopy then 3D Fluoroscopy
Arm Type
Experimental
Arm 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".
Intervention Type
Device
Intervention Name(s)
2D Fluoroscopy
Intervention 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 i.e. 2D Fluoroscopy using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system.
Intervention Type
Device
Intervention Name(s)
3D Fluoroscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy
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 (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.
Time Frame
Immediately at the time of 3D Fluoroscopy
Secondary Outcome Measure Information:
Title
Number of Participants for Which the Surgeon Changed Reduction of Fibular Fracture Reduction Because of Information Provided by 3D Fluoroscopy
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 (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.
Time Frame
Immediately at the time of 3D Fluoroscopy
Title
Pain as Assessed by the AOFAS Score
Description
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Time Frame
3 months after 3D Fluoroscopy
Title
Function as Assessed by the AOFAS Score
Description
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Time Frame
3 months after 3D Fluoroscopy
Title
Alignment as Assessed by the AOFAS Score
Description
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Time Frame
3 months after 3D Fluoroscopy
Title
Pain as Assessed by the AOFAS Score
Description
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Time Frame
6 months after 3D Fluoroscopy
Title
Function as Assessed by the AOFAS Score
Description
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Time Frame
6 months after 3D Fluoroscopy
Title
Alignment as Assessed by the AOFAS Score
Description
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Time Frame
6 months after 3D Fluoroscopy
Title
Pain as Assessed by the PROMIS Score
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Time Frame
3 months after 3D Fluoroscopy
Title
Function as Assessed by the PROMIS Score
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Time Frame
3 months after 3D Fluoroscopy
Title
Pain as Assessed by the PROMIS Score
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Time Frame
6 months after 3D Fluoroscopy
Title
Function as Assessed by the PROMIS Score
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Time Frame
6 months after 3D Fluoroscopy
Title
Number of Participants With Syndesmotic Malreduction as Assessed by a Single Postoperative Bilateral CT Scan
Description
Malreduction will be determined by comparing uninjured ankle to the injured ankle
Time Frame
1 day after 3D Fluoroscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua L Gary, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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