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

NCT ID: NCT00556010

Last Updated: 2012-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ankle Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Yorm A Weil, M.D

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Roy Davidovitch, MD

Role: STUDY_CHAIR

NYU school of Medicine, Hospital for Joint Diseases , New York, U.S.A

Rami Mosheiff, MD

Role: STUDY_CHAIR

Hadassah Medical Organization

Kenneth Egol, M.D

Role: STUDY_CHAIR

NYU school of Medicine, Hospital for Joint Diseases, New York, USA

Amal Khoury, MD

Role: STUDY_CHAIR

Hadassah Medical Organization

Meir Liebergall, MD

Role: STUDY_DIRECTOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization.

Jerusalem, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 24132357 (View on PubMed)

Other Identifiers

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WEIL-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id