An Evaluation Of Healthy Ankle Motion And Morphology | NCT03619382

Studies
An Evaluation Of Healthy Ankle Motion And Morphology

NCT03619382

Sponsor

Paragon 28

Status

Completed

Last Update Posted

Jun 18, 2021Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Healthy Ankle

Interventions

Cone Beam Computed Tomography
Radiographs

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2018Actual

Primary Completion Date

May 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Jul 11, 2018

First Submission Date that Met QC Criteria

Aug 6, 2018

First Posted Date

Aug 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2021

Last Update Posted Date

Jun 18, 2021Actual

Name	Class
Focus Medical Design and Development	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy		Subjects identified to have a healthy foot/ankle	Radiation: Cone Beam Computed Tomography Radiation: Radiographs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cone Beam Computed Tomography	Radiation	Computer tomography (CT) of the foot/ankle for determination of motion and morphology	Healthy

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Volunteers who have a healthy ankle

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Clancy, DPM	Orthopedic Center of Palm Beach County	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Orthopedic Center of Palm Beach County		Atlantis	Florida	33462	United States

References Module

Citations

Not provided

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena