An observational study in Healthy Ankle, sponsored by Paragon 28. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-18.
Sponsored by Paragon 28 (part of Zimmer Biomet) · Observational
Determine motion and morphology of the healthy ankle during simulated gait.
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.
Paragon 28 is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
First submitted before Paragon 28 became part of Zimmer Biomet.
Counted across the registry records on this site, refreshed daily.
Volunteers who have a healthy ankle
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects identified to have a healthy foot/ankle
Radiation: Cone Beam Computed Tomography · Radiation: Radiographs
Computer tomography (CT) of the foot/ankle for determination of motion and morphology
Standard radiographs of the foot/ankle as part of the screening criteria
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 (°).
Time frame: 1 day
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.
Time frame: 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.
Time frame: 1 day
Plan to share: No
Ran from Jul 2018 to primary completion in May 2020, 22 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.