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

Primary Purpose

Ankle Injuries

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Antiglide Plate
Lateral Plate
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Injuries focused on measuring Ankle Fractures, Displaced Lateral Malleolus Fractures, Antiglide Plating, Lateral Plating

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University
  • Boston Medical Center
  • Orthopaedic Associates of Michigan
  • Hennepin County Medical Center
  • Barnes-Jewish Hospital
  • New York Hospital for Joint Diseases
  • Ohio State University Medical Center
  • University of Oklahoma/ Health Science
  • Orthopaedic Specialty Associates Fort Worth
  • Dalhousie University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Randomized treatment; antiglide plate

Randomized treatment; lateral plate

Arm Description

Randomized treatment; antiglide plate

Randomized treatment; lateral plate

Outcomes

Primary Outcome Measures

Percentage of Nonpalpable Hardware
Percentage of Participants with Nonpalpable Hardware

Secondary Outcome Measures

Percentage Normal Peroneal Tendons
Percentage of Participants with Normal Peroneal Tendons
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.
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.
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.

Full Information

First Posted
July 16, 2008
Last Updated
February 14, 2017
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00718302
Brief Title
A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures
Official Title
Ankle Fracture Plating: A Multicenter Randomized Trial Comparing Lateral and Antiglide Plating in Displaced Lateral Malleolus Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Injuries
Keywords
Ankle Fractures, Displaced Lateral Malleolus Fractures, Antiglide Plating, Lateral Plating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomized treatment; antiglide plate
Arm Type
Experimental
Arm Description
Randomized treatment; antiglide plate
Arm Title
Randomized treatment; lateral plate
Arm Type
Experimental
Arm Description
Randomized treatment; lateral plate
Intervention Type
Device
Intervention Name(s)
Antiglide Plate
Intervention Description
A plate is placed behind the broken ankle and secured with screws
Intervention Type
Device
Intervention Name(s)
Lateral Plate
Intervention Description
A metal plate is placed to the side of the broken ankle and is secured with screws
Primary Outcome Measure Information:
Title
Percentage of Nonpalpable Hardware
Description
Percentage of Participants with Nonpalpable Hardware
Time Frame
3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Percentage Normal Peroneal Tendons
Description
Percentage of Participants with Normal Peroneal Tendons
Time Frame
3 months, 6 months, 12 months
Title
American Orthopedic Foot and Ankle Society Score (AOFAS) Scores
Description
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.
Time Frame
3 months, 6 months, 12 months
Title
The Short Musculoskeletal Functional Assessment (SMFA) Score
Description
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.
Time Frame
3 months, 6 months, 9 months
Title
SMFA - Bother Index
Description
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.
Time Frame
3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Tornetta, MD
Organizational Affiliation
Boston University / Boston Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Phieffer, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Orthopaedic Associates of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Barnes-Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York Hospital for Joint Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma/ Health Science
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73190
Country
United States
Facility Name
Orthopaedic Specialty Associates Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Dalhousie University
City
Halifax, Nova Scotia
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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