N/A
N=97
An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA
Orthopedic Disorder · Trauma · Ankle Fractures · Post-traumatic Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03809520 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Changes in the Ankle Joint Space Width Between Baseline and Final Follow-up — 0.912 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- pedCAT (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- J L Marsh
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in the Ankle Joint Space Width Between Baseline and Final Follow-up |
0.912 | — |
| SECONDARY Change in Ankle Pain |
57.2 | — |
| SECONDARY Change in Ankle Function |
12.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03809520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.