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

NCT00556010 | Completed

• 1 other identifier: WEIL-HMO-CTIL
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankle Injuries

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with fracture in the ankle with Syndesmosis disruption

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization.

Jerusalem, Israel

Location

Related Publications (1)

• 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.

  PMID: 24132357 DERIVED

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Yorm A Weil, M.D

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

• Meir Liebergall, MD

  Hadassah Medical Organization

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 9, 2007
• Study Start: January 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 20, 2012

Record last verified: 2011-04

Locations

IL (1)