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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Paul Tornetta, III, M.D., Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00718302
First received: July 16, 2008
Last updated: February 14, 2017
Last verified: February 2017
  Purpose
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).

Condition Intervention
Ankle Injuries Device: Antiglide Plate Device: Lateral Plate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ankle Fracture Plating: A Multicenter Randomized Trial Comparing Lateral and Antiglide Plating in Displaced Lateral Malleolus Fractures

Resource links provided by NLM:


Further study details as provided by Paul Tornetta, III, M.D., Boston Medical Center:

Primary Outcome Measures:
  • Percentage of Nonpalpable Hardware [ Time Frame: 3 months, 6 months, 12 months ]
    Percentage of Participants with Nonpalpable Hardware


Secondary Outcome Measures:
  • Percentage Normal Peroneal Tendons [ Time Frame: 3 months, 6 months, 12 months ]
    Percentage of Participants with Normal Peroneal Tendons

  • American Orthopedic Foot and Ankle Society Score (AOFAS) Scores [ Time Frame: 3 months, 6 months, 12 months ]
    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 [ Time Frame: 3 months, 6 months, 9 months ]
    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 [ Time Frame: 3 months, 6 months, 12 months ]
    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.


Enrollment: 249
Study Start Date: June 2008
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Randomized treatment; antiglide plate
Randomized treatment; antiglide plate
Device: Antiglide Plate
A plate is placed behind the broken ankle and secured with screws
Experimental: Randomized treatment; lateral plate
Randomized treatment; lateral plate
Device: Lateral Plate
A metal plate is placed to the side of the broken ankle and is secured with screws

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718302

Locations
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Orthopaedic Associates of Michigan
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New York
New York Hospital for Joint Diseases
New York, New York, United States, 10003
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma/ Health Science
Oklahoma City, Oklahoma, United States, 73190
United States, Texas
Orthopaedic Specialty Associates Fort Worth
Fort Worth, Texas, United States, 76104
Canada
Dalhousie University
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Boston Medical Center
Investigators
Principal Investigator: Paul Tornetta, MD Boston University / Boston Medical Center
Principal Investigator: Laura Phieffer, MD Ohio State University
  More Information

Responsible Party: Paul Tornetta, III, M.D., Principal Investigator, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00718302     History of Changes
Other Study ID Numbers: H-27190
Study First Received: July 16, 2008
Results First Received: January 28, 2015
Last Updated: February 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Paul Tornetta, III, M.D., Boston Medical Center:
Ankle Fractures
Displaced Lateral Malleolus Fractures
Antiglide Plating
Lateral Plating

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Ankle Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 18, 2017