NCT03809520

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: J L Marsh · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Individuals who present with an intra-articular of the tibial plafond will be consented to participate in this study. We will obtain pedCAT scans at 6, 12, and 18 months post-injury, as well as several questionnaires that will be administered during the clinical visits. We will also review the subjects' electronic medical record for data related to the injury, including the timing and mechanism of injury, time from injury to surgery, length of hospital stay, any complications and/or subsequent ankle surgeries, as well as any clinic notes, imaging, and/or outcomes scores related to the calcaneus fracture.

Conditions

• Orthopedic Disorder
• Trauma
• Ankle Fractures
• Post-traumatic Osteoarthritis

Interventions

Type	Name	Description
RADIATION	pedCAT	Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.

Timeline

• Start date: 2017-01-01
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2019-01-18
• Last updated: 2023-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study