N/A
N=233
A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures
Ankle Injuries
Bottom Line
View on ClinicalTrials.gov: NCT00718302 ↗Enrolled (actual)
233
Serious AEs
0.9%
Results posted
Mar 2017
Primary outcome: Primary: Percentage of Nonpalpable Hardware — 71; 55; 64; 66 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Antiglide Plate (Device); Lateral Plate (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Nonpalpable Hardware |
71; 55; 64; 66; 51; 44 | — |
| SECONDARY Percentage Normal Peroneal Tendons |
88; 88; 91; 92; 88; 90 | — |
| SECONDARY American Orthopedic Foot and Ankle Society Score (AOFAS) Scores |
81.6; 82.8; 87.24; 87.43; 90.11; 89.44 | — |
| SECONDARY The Short Musculoskeletal Functional Assessment (SMFA) Score |
25.1; 27.2; 15.3; 18.6; 11.6; 15.6 | — |
| SECONDARY SMFA - Bother Index |
23.1; 25.9; 14.1; 19.1; 12.8; 16.6 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00718302). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.