An Evaluation Of Healthy Ankle Motion And Morphology In Different Phases Of Simulated Gait Using A Weight-bearing CBCT Scan

Paragon 281 site in 1 country19 target enrollmentJuly 16, 2018

ConditionsHealthy Ankle

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy Ankle
Sponsor: Paragon 28
Enrollment: 19
Locations: 1
Primary Endpoint: Relative rotations of bones
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 16, 2018

End Date

December 31, 2020

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Paragon 28

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The subject self-reports having a right healthy ankle.
•The subject agrees to comply with the requirements of the study and complete the study measures.
•The subject is between the ages of 18 and
•The subject is willing to provided written informed consent.

Exclusion Criteria

•The subject is pregnant.
•The subject reports having been diagnosed with any form of diabetes.
•The subject reports having surgery on the right foot, right ankle and/or right knee.
•The subject reports a history of repeated ankle sprains or injuries to the right ankle.
•The subject reports a history of instability of the right ankle.
•The subject reports chronic or recurring pain of the right ankle.
•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.

Outcomes

Primary Outcomes

Relative rotations of bones

Time Frame: 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 (°).