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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03163017
Recruitment Status : Completed
First Posted : May 22, 2017
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
AO Trauma North America
Information provided by (Responsible Party):
Joshua L Gary, 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.

Condition or disease Intervention/treatment Phase
Displaced Ankle Fractures Device: 2D Fluoroscopy Device: 3D Fluoroscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Intraoperative 3D Fluoroscopy Accurately Assess Syndesmotic Reduction Following Traumatic Ankle Injury?
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : September 11, 2018
Actual Study Completion Date : September 11, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163017


Locations
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United States, Texas
The University of Texas at Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
AO Trauma North America
Investigators
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Principal Investigator: Joshua L Gary, MD The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Joshua L Gary, The University of Texas Health Science Center, Houston:
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Responsible Party: Joshua L Gary, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03163017    
Other Study ID Numbers: HSC-MS-16-0840
First Posted: May 22, 2017    Key Record Dates
Results First Posted: September 12, 2019
Last Update Posted: September 12, 2019
Last Verified: August 2019

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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
Keywords provided by Joshua L Gary, The University of Texas Health Science Center, Houston:
3D Fluoroscopy
Additional relevant MeSH terms:
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Ankle Fractures
Ankle Injuries
Fractures, Bone
Wounds and Injuries
Leg Injuries