NCT02599441CompletedNot Applicable
Comparison of a Novel Weight Bearing Cone-beam Computed Tomography (CT) Scan to Gravity Stress X-ray for Determining Instability of Supination-external Rotation Type Ankle Fractures
State University of New York at Buffalo1 site in 1 country9 target enrollmentStarted: February 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Medial Clear Space Distance in the Ankle Joint
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Medial Clear Space Distance in the Ankle Joint
Time Frame: Baseline- single-day study
measured on weight bearing CBCT
Secondary Outcomes
- Medial Clear Space on Standard Xray(Baseline)
- Medial Clear Space on Gravity Stress Xray(Baseline)
Investigators
John Marzo
Associate Professor of Clinical Orthopaedics
State University of New York at Buffalo
Study Sites (1)
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