Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00556010
First received: November 8, 2007
Last updated: July 19, 2012
Last verified: April 2011

November 8, 2007
July 19, 2012
January 2009
July 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00556010 on ClinicalTrials.gov Archive Site
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Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption
Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption

Ankle fractures are common injuries that are being operated routinely. In order to restore the long term function and prevent arthritis of the ankle the broken fragments should be put in place precisely. Inadequate reduction can result in pain and long term disability. Recently, based on MRI studies and clinical studies, a significant number of ankle fractures are apparently fixed with less than optimal results. We suggest that the use of a new device that enables better three dimensional imaging will improve the quality of operations performed for ankle fractures.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

patients with fracture in the ankle with Syndesmosis disruption

Ankle Injuries
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with unstable ankle fractures (as classified by the AO as 44B 44C by Lauge Hansen PER4 or SER4) amenable to open reduction and internal fixation.
  2. Patients with syndesmotic rupture as evident from the injury films or during clinical testing in the OR be included in the study.
  3. Intraoperative testing will include both a cotton Test and a stress view obtained after bimalleolar fixation has been attained.
  4. A positive syndesmotic injury will be defined by the criteria of Pettrone et al as follows: a tib/fib clear space >5mm or tib/fib overlap of <10mm (on the AP view), or a tib/fib overlap of <1mm on the mortise view.

Exclusion Criteria:

  1. Patients with a pilon fracture (i.e. plafond fractures AO type 43B and C) will be excluded even if associated with a fibula fracture and syndesmosis disruption.
  2. Patients with contraindications to operative treatment and diabetics
  3. Women of childbearing age will be excluded if they present with a positive pre-op Beta HCG test or if they refuse a B HCG test.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00556010
WEIL-HMO-CTIL
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Hadassah Medical Organization
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Principal Investigator: Yorm A Weil, M.D Hadassah Medical Organization
Study Chair: Roy Davidovitch, MD NYU school of Medicine, Hospital for Joint Diseases , New York, U.S.A
Study Chair: Rami Mosheiff, MD Hadassah Medical Organization
Study Chair: Kenneth Egol, M.D NYU school of Medicine, Hospital for Joint Diseases, New York, USA
Study Chair: Amal Khoury, MD Hadassah Medical Organization
Study Director: Meir Liebergall, MD Hadassah Medical Organization
Hadassah Medical Organization
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP