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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Ankle Fracture Plating: A Multicenter Randomized Trial Comparing Lateral and Antiglide Plating in Displaced Lateral Malleolus Fractures

Conditions
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Ankle Injuries

Intervention / Treatment
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* Device: Antiglide Plate
* Device: Lateral Plate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle Fractures, Displaced Lateral Malleolus Fractures, Antiglide Plating, Lateral Plating