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OpenTrials
Completed

NCT Number: NCT03163017

Assessment of Ability of 3D Fluorscopy in Aiding Accurate 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.

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Key information

Conditions

Displaced Ankle Fractures

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas at Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. Pain as Assessed by the AOFAS Score

    Time frame: 3 months after 3D Fluoroscopy

    The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores

  3. Function as Assessed by the AOFAS Score

    Time frame: 3 months after 3D Fluoroscopy

    The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores

  4. Alignment as Assessed by the AOFAS Score

    Time frame: 3 months after 3D Fluoroscopy

    The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores

  5. Pain as Assessed by the AOFAS Score

    Time frame: 6 months after 3D Fluoroscopy

    The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores

  6. Function as Assessed by the AOFAS Score

    Time frame: 6 months after 3D Fluoroscopy

    The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores

  7. Alignment as Assessed by the AOFAS Score

    Time frame: 6 months after 3D Fluoroscopy

    The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores

  8. Pain as Assessed by the PROMIS Score

    Time frame: 3 months after 3D Fluoroscopy

    Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures

  9. Function as Assessed by the PROMIS Score

    Time frame: 3 months after 3D Fluoroscopy

    Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures

  10. Pain as Assessed by the PROMIS Score

    Time frame: 6 months after 3D Fluoroscopy

    Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures

  11. Function as Assessed by the PROMIS Score

    Time frame: 6 months after 3D Fluoroscopy

    Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures

  12. Number of Participants With Syndesmotic Malreduction as Assessed by a Single Postoperative Bilateral CT Scan

    Time frame: 1 day after 3D Fluoroscopy

    Malreduction will be determined by comparing uninjured ankle to the injured ankle

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • AO Trauma North America

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 22, 2017
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.