Healthy Ankle
Conditions
Keywords
ankle
Brief summary
Determine motion and morphology of the healthy ankle during simulated gait.
Detailed description
Healthy volunteers will undergo weight-bearing, cone beam CT scans of their foot/ankle during 3 phases of simulated gait. Motion and morphology of the foot and ankle will be quantified and analyzed.
Interventions
RADIATIONCone Beam Computed Tomography
Computer tomography (CT) of the foot/ankle for determination of motion and morphology
RADIATIONRadiographs
Standard radiographs of the foot/ankle as part of the screening criteria
Sponsors
Focus Medical Design and Development
Paragon 28
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject self-reports having a right healthy ankle. 2. The subject agrees to comply with the requirements of the study and complete the study measures. 3. The subject is between the ages of 18 and 65. 4. The subject is willing to provided written informed consent.
Exclusion criteria
1. The subject is pregnant. 2. The subject reports having been diagnosed with any form of diabetes. 3. The subject reports having surgery on the right foot, right ankle and/or right knee. 4. The subject reports a history of repeated ankle sprains or injuries to the right ankle. 5. The subject reports a history of instability of the right ankle. 6. The subject reports chronic or recurring pain of the right ankle. 7. The subject is: a prisoner, unable to understand what participation in the study entails, mentally incompetent, and/or known abuser of alcohol and/or drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative rotations of bones | 1 day | Determine relative tri-axial rotations between bones of the foot and ankle using reconstructed 3-dimensional computer models. All rotations will be measured in degrees (°). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative translations of bones | 1 day | Determine relative multi-directional translation between bones of the foot and ankle using reconstructed 3-dimensional computer models. All translations will be measured in mm. |
| Morphology - size and shape of the bones of the foot and ankle | 1 day | Evaluate the size and shape of the bones of the foot and ankle using reconstructed 3-dimensional computer models relative to height, weight, body mass index and gender. All distances will be measured in mm. |
Countries
United States
Outcome results
None listed