Computed Tomography for Evaluating Supination-external Rotation Type Ankle Fractures

NCT ID: NCT02599441

Last Updated: 2019-10-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-02-02

Brief Summary

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To compare measures of ankle stability from an investigational cone beam computed tomography scanner to gravity stress X-ray in patients who have unstable supination-external rotation ankle fractures.

Detailed Description

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Conditions

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Supination-external Rotation Ankle Fractures

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Ankle fracture cases

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* willing \& able to provide written informed consent
* at least 18 years-old
* have medial clear space measuring less than 5 mm with clinical suspicion of instability and would normally require a gravity stress X-ray

Exclusion Criteria

* pregnant (females)
* prisoners
* open fracture
* clinical signs of foot deformity
* previous foot trauma or surgery on the affected foot
* significant osteoarthritis or pre-existing ligamentous instability or pain in the affected foot
* unable to stand in the weight bearing position during the CT scan
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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John Marzo

Associate Professor of Clinical Orthopaedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Marzo, MD

Role: PRINCIPAL_INVESTIGATOR

UBMB Orthopaedics & Sports Medicine

Locations

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UBMD Orthopaedics & Sports Medicine

Buffalo, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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733368-1

Identifier Type: -

Identifier Source: org_study_id

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