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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
History of Changes
  Purpose

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.


Condition
Ankle Injuries

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intraoperative Three Dimensional Fluoroscopy Compared to Standard Fluoroscopy for the Assessment of Reduction of Ankle Fractures With Syndesmosis Disruption

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 40
Study Start Date: January 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with fracture in the ankle with Syndesmosis disruption

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556010

Locations
Israel
Hadassah Medical Organization.
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00556010     History of Changes
Other Study ID Numbers: WEIL-HMO-CTIL
Study First Received: November 8, 2007
Last Updated: July 19, 2012
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Ankle Injuries
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013