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

This study is currently recruiting participants.

Verified by Hadassah Medical Organization, November 2008

Sponsored by:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00556010

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

MedlinePlus related topics: Ankle Injuries and Disorders Fractures

U.S. FDA Resources

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

Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	September 2009
Estimated Study Completion Date:	January 2010

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:

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.
Patients with syndesmotic rupture as evident from the injury films or during clinical testing in the OR be included in the study.
Intraoperative testing will include both a cotton Test and a stress view obtained after bimalleolar fixation has been attained.
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:

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.
Patients with contraindications to operative treatment and diabetics
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

Contacts

Contact: Arik Tzukert, DMD

: 00 972 2 6776095

arik@hadassah.org.il

Locations

Israel
Hadassah Medical Organization.	Recruiting
Jerusalem, Israel

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

Principal Investigator:	Yorm A Weil, M.D	Hadassah Medical Organization, Jerusalem, Israel
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, Jerusalem, Israel
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, Jerusalem, Israel
Study Director:	Meir Liebergall, MD	Hadassah Medical Organization, Jerusalem, Israel

More Information

Study ID Numbers:	WEIL-HMO-CTIL
Study First Received:	November 8, 2007
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00556010
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Ankle Injuries
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

ClinicalTrials.gov processed this record on January 15, 2009