N/A N=30 Treatment

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

Displaced Ankle Fractures

Bottom Line

View on ClinicalTrials.gov: NCT03163017 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy — 14 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 2D Fluoroscopy (Device); 3D Fluoroscopy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy	14	—
SECONDARY Number of Participants for Which the Surgeon Changed Reduction of Fibular Fracture Reduction Because of Information Provided by 3D Fluoroscopy	—	—
SECONDARY Pain as Assessed by the AOFAS Score	—	—
SECONDARY Function as Assessed by the AOFAS Score	—	—
SECONDARY Alignment as Assessed by the AOFAS Score	—	—
SECONDARY Pain as Assessed by the AOFAS Score	—	—
SECONDARY Function as Assessed by the AOFAS Score	—	—
SECONDARY Alignment as Assessed by the AOFAS Score	—	—
SECONDARY Pain as Assessed by the PROMIS Score	—	—
SECONDARY Function as Assessed by the PROMIS Score	—	—
SECONDARY Pain as Assessed by the PROMIS Score	—	—
SECONDARY Function as Assessed by the PROMIS Score	—	—
SECONDARY Number of Participants With Syndesmotic Malreduction as Assessed by a Single Postoperative Bilateral CT Scan	3	—

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03163017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.