CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 249 enrolled
Drug / intervention
Antiglide Plate +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/NCT00718302
NCT00718302N/ACompleted

Ankle Fracture Plating: A Multicenter Randomized Trial Comparing Lateral and Antiglide Plating in Displaced Lateral Malleolus Fractures

Boston Medical Center·interventional·Posted Jul 18, 2008·Updated Mar 29, 2017

In Brief

A clinical study evaluating Antiglide Plate and Lateral Plate for Ankle Injuries. Completed, enrolled 249 participants across 10 sites in 2 countries.

Detailed Summary

The role of operative fixation of unstable, displaced lateral malleolus fractures is well-established (Mayer, Mak, and Yablon). However, the optimal type of fixation remains the subject of debate. Lag screw fixation alone is only appropriate for long oblique fractures in younger patients (Tornetta). For all other patients, the choices for fibular stabilization most commonly involve the use of plates and screws which can be placed on either the lateral or posterior side of the bone, with or without lag screws. Lateral plating remains the most popular option, but since the description of posterior plating in 1982 (Brunner), reports in the literature have demonstrated some advantages of posterior over lateral plating (Ostrum, Treadwell, Winkler, and Wissing) . These advantages include less dissection, less palpable hardware, and decreased likelihood of intra-articular screw placement. However, there is only a single retrospective study in the published literature directly comparing these two methods (Lamontagne).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkle Injuries
CountriesCanada, United States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 18, 2008
Enrollment StartJun 1, 2008
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 18.0 years ago

Interventions

Antiglide Platedevice

A plate is placed behind the broken ankle and secured with screws

Lateral Platedevice

A metal plate is placed to the side of the broken ankle and is secured with screws