Clinical trial NCT03163017: 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
Overall status: COMPLETED
Phase: NA
Conditions: Displaced Ankle Fractures
Keywords: 3D Fluoroscopy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: AO Trauma North America
First posted: 2017-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy
timeFrame: Immediately at the time of 3D Fluoroscopy
Secondary outcomes:
measure: Number of Participants for Which the Surgeon Changed Reduction of Fibular Fracture Reduction Because of Information Provided by 3D Fluoroscopy
timeFrame: Immediately at the time of 3D Fluoroscopy
measure: Pain as Assessed by the AOFAS Score
timeFrame: 3 months after 3D Fluoroscopy
measure: Function as Assessed by the AOFAS Score
timeFrame: 3 months after 3D Fluoroscopy
measure: Alignment as Assessed by the AOFAS Score
timeFrame: 3 months after 3D Fluoroscopy
measure: Pain as Assessed by the AOFAS Score
timeFrame: 6 months after 3D Fluoroscopy
measure: Function as Assessed by the AOFAS Score
timeFrame: 6 months after 3D Fluoroscopy
measure: Alignment as Assessed by the AOFAS Score
timeFrame: 6 months after 3D Fluoroscopy
measure: Pain as Assessed by the PROMIS Score
timeFrame: 3 months after 3D Fluoroscopy
measure: Function as Assessed by the PROMIS Score
timeFrame: 3 months after 3D Fluoroscopy
measure: Pain as Assessed by the PROMIS Score
timeFrame: 6 months after 3D Fluoroscopy
measure: Function as Assessed by the PROMIS Score
timeFrame: 6 months after 3D Fluoroscopy
measure: Number of Participants With Syndesmotic Malreduction as Assessed by a Single Postoperative Bilateral CT Scan
timeFrame: 1 day after 3D Fluoroscopy
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas at Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Joshua L Gary, MD
role: PRINCIPAL_INVESTIGATOR
References: