CompletedNot Applicable

An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA

United States97 participantsStarted 2017-02-01

Plain-language summary

The immediate goal of the proposed research is to test the value of a new low-cost, low-dose standing CT system for efficient early detection of both joint degeneration and elevated contact stress. The standing CT scanner holds promise for detecting arthritic changes earlier than other imaging modalities because of the combination of its 3D nature and ability to image joints in a weight-bearing pose. A secondary goal of the proposed research is to enable predictive models for osteoarthritis risk based on measures of post treatment contact stress, both to inform treatment and so that new interventions can be tested in a manner incorporating risk stratification.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Individuals 18 to 70 years old Sustained an intra-articular fracture of the tibial plafond Indicated for operative treatment Present for treatment within 4 weeks of injury Exclusion Criteria: * Women who are pregnant or planning on becoming pregnant Individuals younger than 18 and older than 70

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this trial has already been completed, would the imaging framework it developed — measuring changes in ankle joint space width over time — be available or relevant to monitoring my own ankle fracture recovery?
2This study focused on tracking post-traumatic osteoarthritis after ankle fractures using imaging — do you think the approach it tested could change how my progress is monitored compared to standard X-rays or checkups?
3Because this was listed as a non-interventional or framework-development study rather than a treatment trial, does that mean its findings are more about diagnosis and tracking than about a specific therapy I could receive?
4Given that this trial specifically studied the link between ankle fractures and post-traumatic osteoarthritis, what signs of early joint space changes should I watch for after my own fracture, and how often should we be imaging my ankle?
5Are there other active trials or treatment studies building on this kind of imaging framework that might be worth looking into, since this one is already completed?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in the Ankle Joint Space Width Between Baseline and Final Follow-up

Timeframe: Final imaging assessed at 18 months or up to 5 years post-injury

Trial details

NCT IDNCT03809520

SponsorJ L Marsh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31

Results submitted2025-11-04

View on ClinicalTrials.gov More Orthopedic Disorder trials