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N/A N=233 Randomized Treatment

A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures

Ankle Injuries

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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