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

Not Applicable

Recruiting

• Conditions: Orthopedic Disorder; Ankle Fractures; Trauma; Post-traumatic Osteoarthritis
• Interventions: Radiation: pedCAT

• Registration Number: NCT03809520
• Lead Sponsor: J L Marsh

Brief 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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-18
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Changes in the ankle joint space width	18 months	Tracking longitudinal changes in the 3D joint space width as seen in pedCAT imaging compared to baseline pedCAT imaging

Secondary Outcome Measures

Name	Time	Method
Change in ankle function	18 months	Subjective measure of foot and ankle function gathered by patient reported outcomes questionnaires
Change in ankle pain	18 months	Subjective measure of foot and ankle pain gathered by patient reported outcomes questionnaires

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States