A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures
Completed · Not applicable
Conditions studied: Ankle Injuries
In brief
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).
Key facts
- Study ID
- NCT00718302
- Run by
- Boston Medical Center
- People needed
- 249
- Starts
- 2008-06-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2017-03-29
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Indiana University — Indianapolis, Indiana, United States
- Boston Medical Center — Boston, Massachusetts, United States
- Orthopaedic Associates of Michigan — Grand Rapids, Michigan, United States
- Hennepin County Medical Center — Minneapolis, Minnesota, United States
- Barnes-Jewish Hospital — St Louis, Missouri, United States
- New York Hospital for Joint Diseases — New York, New York, United States
- Ohio State University Medical Center — Columbus, Ohio, United States
- University of Oklahoma/ Health Science — Oklahoma City, Oklahoma, United States
- Orthopaedic Specialty Associates Fort Worth — Fort Worth, Texas, United States
- Dalhousie University — Halifax, Nova Scotia, Canada
Full record on ClinicalTrials.gov
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