A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures
Ankle Fracture Plating: A Multicenter Randomized Trial Comparing Lateral and Antiglide Plating in Displaced Lateral Malleolus Fractures
1 other identifier
interventional
249
2 countries
10
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2008
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 16, 2008
CompletedFirst Posted
Study publicly available on registry
July 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
March 29, 2017
CompletedMarch 29, 2017
February 1, 2017
4.5 years
July 16, 2008
January 28, 2015
February 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Nonpalpable Hardware
Percentage of Participants with Nonpalpable Hardware
3 months, 6 months, 12 months
Secondary Outcomes (4)
Percentage Normal Peroneal Tendons
3 months, 6 months, 12 months
American Orthopedic Foot and Ankle Society Score (AOFAS) Scores
3 months, 6 months, 12 months
The Short Musculoskeletal Functional Assessment (SMFA) Score
3 months, 6 months, 9 months
SMFA - Bother Index
3 months, 6 months, 12 months
Study Arms (2)
Randomized treatment; antiglide plate
EXPERIMENTALRandomized treatment; antiglide plate
Randomized treatment; lateral plate
EXPERIMENTALRandomized treatment; lateral plate
Interventions
A plate is placed behind the broken ankle and secured with screws
A metal plate is placed to the side of the broken ankle and is secured with screws
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Indiana University
Indianapolis, Indiana, 46202, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, 49503, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
New York Hospital for Joint Diseases
New York, New York, 10003, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Oklahoma/ Health Science
Oklahoma City, Oklahoma, 73190, United States
Orthopaedic Specialty Associates Fort Worth
Fort Worth, Texas, 76104, United States
Dalhousie University
Halifax, Nova Scotia, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paul Tornetta, III, MD
- Organization
- Boston Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Tornetta, MD
Boston University / Boston Medical Center
- PRINCIPAL INVESTIGATOR
Laura Phieffer, MD
Ohio State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 16, 2008
First Posted
July 18, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
March 29, 2017
Results First Posted
March 29, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share