Supination-external Rotation Ankle Fractures
Conditions
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.
Interventions
None listed
Sponsors
State University of New York at Buffalo
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medial Clear Space Distance in the Ankle Joint | Baseline- single-day study | measured on weight bearing CBCT |
Secondary
| Measure | Time frame |
|---|---|
| Medial Clear Space on Gravity Stress Xray | Baseline |
| Medial Clear Space on Standard Xray | Baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ankle Fracture Cases 9 ankle fractures included in the study | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Ankle Fracture Cases |
|---|---|
| Age, Continuous | 50.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Medial Clear Space Distance in the Ankle Joint
measured on weight bearing CBCT
Time frame: Baseline- single-day study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle Fracture Cases | Medial Clear Space Distance in the Ankle Joint | 1.41 mm | Standard Deviation 0.41 |
Secondary
Medial Clear Space on Gravity Stress Xray
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle Fracture Cases | Medial Clear Space on Gravity Stress Xray | 5.82 mm | Standard Deviation 1.93 |
Secondary
Medial Clear Space on Standard Xray
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ankle Fracture Cases | Medial Clear Space on Standard Xray | 3.28 mm | Standard Deviation 1.63 |