An Evaluation Of Healthy Ankle Motion And Morphology

NCT03619382 | Completed

• 1 other identifier: P10-SP-0001
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Ankle

Keywords

ankle

Outcome Measures

Primary Outcomes (1)

• Relative rotations of bones

  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 (°).

  1 day

Secondary Outcomes (2)

• Relative translations of bones

  1 day

• Morphology - size and shape of the bones of the foot and ankle

  1 day

Study Arms (1)

Healthy

Subjects identified to have a healthy foot/ankle

Radiation: Cone Beam Computed Tomography; Radiation: Radiographs

Interventions

Cone Beam Computed Tomography RADIATION

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

Healthy

Radiographs RADIATION

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

Healthy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers who have a healthy ankle

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paragon 28: lead
• Focus Medical Design and Development: collaborator

Study Sites (1)

Orthopedic Center of Palm Beach County

Atlantis, Florida, 33462, United States

Location

Related Links

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

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• James Clancy, DPM

  Orthopedic Center of Palm Beach County

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 7, 2018
• Study Start: July 16, 2018
• Primary Completion: May 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)