N/A
N=9
Computed Tomography for Evaluating Supination-external Rotation Type Ankle Fractures
Supination-external Rotation Ankle Fractures
Bottom Line
View on ClinicalTrials.gov: NCT02599441 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Medial Clear Space Distance in the Ankle Joint — 1.41 mm
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medial Clear Space Distance in the Ankle Joint |
1.41 | — |
| SECONDARY Medial Clear Space on Gravity Stress Xray |
5.82 | — |
| SECONDARY Medial Clear Space on Standard Xray |
3.28 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02599441). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.