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OpenTrials
Completed

NCT Number: NCT03619382

An Evaluation Of Healthy Ankle Motion And Morphology

Determine motion and morphology of the healthy ankle during simulated gait.

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Key information

Conditions

Healthy Ankle

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopedic Center of Palm Beach County

Atlantis, Florida, 33462, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 65.
  • 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.

Treatment and study plan

Cone Beam Computed Tomography

Radiation

Computer tomography (CT) of the foot/ankle for determination of motion and morphology

Radiographs

Radiation

Standard radiographs of the foot/ankle as part of the screening criteria

Primary outcomes

  1. 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 (°).

Secondary outcomes

  1. Relative translations of bones

    Time frame: 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.

  2. Morphology - size and shape of the bones of the foot and ankle

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Paragon 28

Industry

Collaborators

  • Focus Medical Design and Development

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 7, 2018
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.