An Evaluation Of Healthy Ankle Motion And Morphology

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Ankle
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Florida
    • Atlantis, Florida, United States, 33462
      • Orthopedic Center of Palm Beach County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Volunteers who have a healthy ankle

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative translations of bones	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.	1 day
Morphology - size and shape of the bones of the foot and ankle	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.	1 day

Collaborators and Investigators

• Sponsor: Paragon 28
• Collaborators: Focus Medical Design and Development
• Investigators: Principal Investigator: James Clancy, DPM, Orthopedic Center of Palm Beach County

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2018
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: August 6, 2018
• First Posted (Actual): August 7, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: ankle
• Other Study ID Numbers: P10-SP-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No