An Evaluation Of Healthy Ankle Motion And Morphology

Completed

• Conditions: Healthy Ankle
• Interventions: Radiation: Cone Beam Computed Tomography; Radiation: Radiographs

• Registration Number: NCT03619382
• Lead Sponsor: Paragon 28

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-07-11
• Study Start: 2018-07-16
• Study First Submitted QC: 2018-08-06
• Study First Posted: 2018-08-07
• Primary Completion: 2020-05-31
• Study Completion: 2020-12-31
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	Cone Beam Computed Tomography	Subjects identified to have a healthy foot/ankle
Healthy	Radiographs	Subjects identified to have a healthy foot/ankle

Primary Outcome Measures

Name	Time	Method
Relative rotations of bones	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

Name	Time	Method
Morphology - size and shape of the bones of the foot and ankle	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.
Relative translations of bones	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.

Trial Locations

Locations (1)

Orthopedic Center of Palm Beach County; 🇺🇸 Atlantis, Florida, United States