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

J L Marsh

Status: Enrolling

Conditions: Post-traumatic Osteoarthritis; Orthopedic Disorder; Trauma; Ankle Fractures

Treatments: Radiation: pedCAT

Study type: Interventional

Funder types: Other

Identifiers

NCT03809520

201612747

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Experimental: pedCAT

Experimental group

Description:

Subjects in this group will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury.

Treatment:

Radiation: pedCAT