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.

Study Overview

• Status: Completed
• Conditions: Ankle Injuries

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Organization.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with fracture in the ankle with Syndesmosis disruption

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Davidovitch RI, Weil Y, Karia R, Forman J, Looze C, Liebergall M, Egol K. Intraoperative syndesmotic reduction: three-dimensional versus standard fluoroscopic imaging. J Bone Joint Surg Am. 2013 Oct 16;95(20):1838-43. doi: 10.2106/JBJS.L.00382.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: November 8, 2007
• First Submitted That Met QC Criteria: November 8, 2007
• First Posted (Estimate): November 9, 2007

Study Record Updates

• Last Update Posted (Estimate): July 20, 2012
• Last Update Submitted That Met QC Criteria: July 19, 2012
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Ankle Injuries; Ankle Fractures
• Other Study ID Numbers: WEIL-HMO-CTIL