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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Mark Zocchi | 617-414-5793 | mark.zocchi@bmc.org |
| Contact: Paul Tornetta, MD | 617-414-5757 | ptornetta@pol.net |
| 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 | |
| Principal Investigator: | Paul Tornetta, MD | Boston University / Boston Medical Center |
| Principal Investigator: | Laura Phieffer, MD | Ohio State University |
More Information
| 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 |
|
Ankle Fractures Displaced Lateral Malleolus Fractures Antiglide Plating Lateral Plating |
|
Ankle Injuries Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Leg Injuries |