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A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures
This study is currently recruiting participants.
Verified by Boston Medical Center, July 2009
First Received: July 16, 2008   Last Updated: July 2, 2009   History of Changes
Sponsor: Boston Medical Center
Information provided by: Boston Medical Center
ClinicalTrials.gov Identifier: NCT00718302
  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: Treatment, Randomized, Open Label, Single Group Assignment
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 Boston Medical Center:

Primary Outcome Measures:
  • Functional Scores: SF12v2, SMFA, AOFAS ankle/hindfoot scale [ Time Frame: Preoperative (or initial hospitalization), 6, 12, 26, and 52 week standard of care visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of functional scores in a priori subgroup: >60 vs <60 years old. [ Time Frame: Discharge 6, 9, and 12 months post-operation ] [ Designated as safety issue: No ]
  • Comparison in functional scores in a priori subgroup: Good bone quality vs poor bone quality [ Time Frame: discharge 6, 9, and 12 months post-operation ] [ Designated as safety issue: No ]
  • Comparison of functional scores in a priori subgroup: Those with syndesmotic injury versus those without. [ Time Frame: discharge 6, 9, and 12 months post-operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: June 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Randomized: Experimental
Randomized treatment
Device: Antiglide Plate
A plate is placed behind the broken ankle and secured with screws
Device: Lateral Plate
A metal plate is placed to the side of the broken ankle and is secured with screws

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718302

Contacts
Contact: Mark Zocchi 617-414-5793 mark.zocchi@bmc.org
Contact: Paul Tornetta, MD 617-414-5757 ptornetta@pol.net

Locations
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Brian Mullis, MD            
Sub-Investigator: Jan Ertl, MD            
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Mark Zocchi     617-414-5793     mark.zocchi@bmc.org    
Principal Investigator: Paul Tornetta, MD            
United States, Michigan
Orthopaedic Associates of Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
Principal Investigator: Cliff Jones, MD            
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Principal Investigator: Andy Schmidt, MD            
Sub-Investigator: Pat Yoon, MD            
United States, Missouri
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Bill Ricci, MD            
United States, New York
New York Hospital for Joint Diseases Recruiting
New York, New York, United States, 10003
Principal Investigator: Ken Egol, MD            
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Laura Phieffer, MD            
United States, Oklahoma
University of Oklahoma/ Health Science Recruiting
Oklahoma City, Oklahoma, United States, 73190
Principal Investigator: Dave Teague, MD            
United States, Texas
Orthopaedic Specialty Associates Fort Worth Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Cory Collinge, MD            
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

No publications provided

Responsible Party: Boston University / Boston Medical Center ( Paul Tornetta, III, M.D. )
Study ID Numbers: H-27190
Study First Received: July 16, 2008
Last Updated: July 2, 2009
ClinicalTrials.gov Identifier: NCT00718302     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Ankle Fractures
Displaced Lateral Malleolus Fractures
Antiglide Plating
Lateral Plating

Additional relevant MeSH terms:
Ankle Injuries
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on February 08, 2010