An observational study in Supination-external Rotation Ankle Fractures, sponsored by State University of New York at Buffalo. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-25.
Sponsored by State University of New York at Buffalo · Observational
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 9 is below the median of 100 across 675 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who have been diagnosed with unstable supination-external rotation type ankle fractures
Exclusion Criteria:
Medial Clear Space Distance in the Ankle Joint
measured on weight bearing CBCT
Time frame: Baseline- single-day study
Medial Clear Space on Gravity Stress Xray
Time frame: Baseline
Medial Clear Space on Standard Xray
Time frame: Baseline
| Milestone | Ankle Fracture Cases |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
measured on weight bearing CBCT
| mm | Ankle Fracture Cases |
|---|---|
| Medial Clear Space Distance in the Ankle Joint | 1.41 ± 0.41 |
| mm | Ankle Fracture Cases |
|---|---|
| Medial Clear Space on Gravity Stress Xray | 5.82 ± 1.93 |
| mm | Ankle Fracture Cases |
|---|---|
| Medial Clear Space on Standard Xray | 3.28 ± 1.63 |
Collected over not monitored beyond the study visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ankle Fracture Cases | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(years) | Ankle Fracture Cases |
|---|---|
| Mean | 50.3 (33 to 61) |
| Sex: Female, Male(Participants) | Ankle Fracture Cases |
|---|---|
| Female | 3 |
| Male | 6 |
| Race (NIH/OMB)(Participants) | Ankle Fracture Cases |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 6 |
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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State University of New York at Buffalo