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

Study Overview
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Brief Summary
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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.

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

Conditions
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Displaced Ankle Fractures

Intervention / Treatment
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* Device: 2D Fluoroscopy
* Device: 3D Fluoroscopy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2D Fluoroscopy then 3D Fluoroscopy<br>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<br>* 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.<br>Device: 3D Fluoroscopy<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D Fluoroscopy