CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
2D Fluoroscopy +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03163017
NCT03163017N/ACompleted

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

The University of Texas Health Science Center, Houston·interventional·Posted May 22, 2017·Updated Sep 12, 2019

In Brief

A clinical study evaluating 2D Fluoroscopy and 3D Fluoroscopy for Displaced Ankle Fractures. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 22, 2017
Enrollment StartMar 1, 2017
Primary CompletionSep 11, 2018
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 9.1 years ago

Interventions

2D Fluoroscopydevice

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 Fluoroscopydevice

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.