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An Evaluation Of Healthy Ankle Motion And Morphology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03619382
Recruitment Status : Active, not recruiting
First Posted : August 7, 2018
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Focus Medical Design and Development
Information provided by (Responsible Party):
Paragon 28

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

Condition or disease Intervention/treatment
Healthy Ankle Radiation: Cone Beam Computed Tomography Radiation: Radiographs

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.

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Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: An Evaluation Of Healthy Ankle Motion And Morphology In Different Phases Of Simulated Gait Using A Weight-bearing CBCT Scan
Actual Study Start Date : July 16, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Group/Cohort Intervention/treatment
Healthy
Subjects identified to have a healthy foot/ankle
Radiation: Cone Beam Computed Tomography
Computer tomography (CT) of the foot/ankle for determination of motion and morphology

Radiation: Radiographs
Standard radiographs of the foot/ankle as part of the screening criteria




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Volunteers who have a healthy ankle
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619382


Locations
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United States, Florida
Orthopedic Center of Palm Beach County
Atlantis, Florida, United States, 33462
Sponsors and Collaborators
Paragon 28
Focus Medical Design and Development
Investigators
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Principal Investigator: James Clancy, DPM Orthopedic Center of Palm Beach County
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Responsible Party: Paragon 28
ClinicalTrials.gov Identifier: NCT03619382    
Other Study ID Numbers: P10-SP-0001
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paragon 28:
ankle