Healthy AnkleNCT03619382
An Evaluation Of Healthy Ankle Motion And Morphology
An observational study of Healthy Ankle, run by Paragon 28 at 1 site in United States.
Trial summary
Determine motion and morphology of the healthy ankle during simulated gait. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Ankle
- What is being tested?
- Cone Beam Computed Tomography and Radiographs
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers who have a healthy ankle
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopedic Center of Palm Beach County
Atlantis, Florida, 33462
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Ankle
- Being tested
- Cone Beam Computed Tomography, Radiographs
- Keywords
- ankle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam Computed TomographyRadiation
Computer tomography (CT) of the foot/ankle for determination of motion and morphology
RadiographsRadiation
Standard radiographs of the foot/ankle as part of the screening criteria
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Subjects identified to have a healthy foot/ankle Receives: Radiation: Cone Beam Computed Tomography; Radiation: Radiographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (°).
Measured: 1 day
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start16 Jul 2018
- Primary completion31 May 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AnkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paragon 28
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Focus Medical Design and Development
- Responsible party
- Sponsor
- Investigators
- James Clancy, DPM, Principal investigator, Orthopedic Center of Palm Beach County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619382
- Sponsor's protocol ID
- P10-SP-0001
- Status last verified
- Jun 2021
- First submitted
- 11 Jul 2018
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation Of Healthy Ankle Motion And Morphology In Different Phases Of Simulated Gait Using A Weight-bearing CBCT Scan
- ClinicalTrials.gov ID
- NCT03619382
- Acronym / sponsor ID
- P10-SP-0001
- Conditions
- Healthy Ankle
- Keywords
- ankle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Paragon 28Industry (pharma, biotech, devices)
- Collaborators
- Focus Medical Design and Development
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Radiation: Cone Beam Computed Tomography, Radiation: RadiographsSubjects identified to have a healthy foot/ankle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers who have a healthy ankle
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone Beam Computed TomographyComputer tomography (CT) of the foot/ankle for determination of motion and morphology | Radiation | Healthy |
| RadiographsStandard radiographs of the foot/ankle as part of the screening criteria | Radiation | Healthy |
Primary outcome
Relative rotations of bones
Time frame: 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 (°).
2 secondary outcomes
Relative translations of bones
Time frame: 1 day
Morphology - size and shape of the bones of the foot and ankle
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Anderle, Mathew R., et al. "A bi-radial approach to define the sagittal geometry of the healthy ankle." Foot and Ankle Surgery (2020).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Clancy, DPM principal investigator
Orthopedic Center of Palm Beach County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Ankle, run by Paragon 28 at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative rotations of bones (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.