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

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).

Study Overview

• Status: Completed
• Conditions: Ankle Injuries
• Intervention / Treatment: Device: Antiglide Plate; Device: Lateral Plate

Detailed Description

Since it was first described in 1982, posterior antiglide plating has been presented as an attractive alternative to lateral plating of distal fibula fractures. Biomechanical studies have shown it to be a stronger construct than lateral plating, and other purported advantages include less dissection, decreased potential for intra-articular screw placement, and less palpable hardware decreasing the need for hardware removal.However, although posterior plating has become an accepted technique for operative management of these injuries, there is little clinical information in the literature regarding this treatment, and only one published retrospective study directly comparing posterior to lateral plating.

In 1996, Ostrum published a prospective study evaluating posterior plating in 32 patients, but only compared his results to a cohort of patients treated with lateral plating that was not part of his actual study group.Patel et al. recently presented a retrospective comparison of both techniques, but their study only included 29 patients in the lateral plating group and 23 in the posterior group.In both these studies, posterior plating was felt to be superior to lateral plating based on both the decrease in complications/re-operations related to symptomatic hardware, and improved function and pain scores.

However, in a much larger study, Lamontagneet al. showed no differences in operative time, complications or hardware removal rates in 193 patients reviewed retrospectively, and concluded that they could not recommend one treatment method over the other. They even elected not to proceed with a planned prospective study based on their results.A recent retrospective analysis of 70 patients showed a 43% incidence of need for hardware removal due to pain, with 30% of these patients having peroneal tendon lesions identified intra-operatively.

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Halifax, Nova Scotia, Canada
    • Dalhousie University
• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Orthopaedic Associates of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital
  • New York
    • New York, New York, United States, 10003
      • New York Hospital for Joint Diseases
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73190
      • University of Oklahoma/ Health Science
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Orthopaedic Specialty Associates Fort Worth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Randomized treatment; antiglide plate	Device: Antiglide Plate; A plate is placed behind the broken ankle and secured with screws
Experimental: Randomized treatment; lateral plate	Device: Lateral Plate; A metal plate is placed to the side of the broken ankle and is secured with screws

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Nonpalpable Hardware	Percentage of Participants with Nonpalpable Hardware	3 months, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SMFA - Bother Index	The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.	3 months, 6 months, 12 months
Percentage Normal Peroneal Tendons	Percentage of Participants with Normal Peroneal Tendons	3 months, 6 months, 12 months
American Orthopedic Foot and Ankle Society Score (AOFAS) Scores	American Orthopedic Foot and Ankle Society Score (AOFAS) score. The questionnaire consists of nine items that are distributed over three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points. A subject can score anywhere from 0-100, 100 being best.	3 months, 6 months, 12 months
The Short Musculoskeletal Functional Assessment (SMFA) Score	The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.	3 months, 6 months, 9 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Paul Tornetta, MD, Boston University / Boston Medical Center; Principal Investigator: Laura Phieffer, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 17, 2008
• First Posted (Estimate): July 18, 2008

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: February 14, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Ankle Fractures; Displaced Lateral Malleolus Fractures; Antiglide Plating; Lateral Plating
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: H-27190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No