An Evaluation Of Healthy Ankle Motion And Morphology

NCT ID: NCT03619382

Last Updated: 2021-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-16

Study Completion Date

2020-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy Ankle

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy

Subjects identified to have a healthy foot/ankle

Cone Beam Computed Tomography

Intervention Type RADIATION

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

Radiographs

Intervention Type RADIATION

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

Interventions

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Cone Beam Computed Tomography

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

Intervention Type RADIATION

Radiographs

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Focus Medical Design and Development

UNKNOWN

Sponsor Role collaborator

Paragon 28

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Clancy, DPM

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Center of Palm Beach County

Locations

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Orthopedic Center of Palm Beach County

Atlantis, Florida, United States

Site Status

Countries

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United States

Related Links

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https://pubmed.ncbi.nlm.nih.gov/33214032/

Anderle, Mathew R., et al. "A bi-radial approach to define the sagittal geometry of the healthy ankle." Foot and Ankle Surgery (2020).

Other Identifiers

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P10-SP-0001

Identifier Type: -

Identifier Source: org_study_id

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