A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures (NCT00718302) | Clinical Trial Compass
CompletedNot Applicable
A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures
United States, Canada249 participantsStarted 2008-06
Plain-language 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).
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 - 85
* Closed Unstable Supination Eversion type Weber B fibula fracture
* Soft tissue amenable to operative treatment
* Opt for surgical treatment of their fracture
* Willing to follow up for 1 year
* Consent to be randomized
Exclusion Criteria:
* Aged \< 18 or over 85
* Open fracture
* Prisoners
* Unlikely to followup
* Non english speaking
* Pre-existing arthrosis of the ankle
* Limitation in lower extremity function that would affect outcome scoring
* Significant anterior comminution precluding antiglide fixation
* Bilateral Fracture
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.