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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03809520
• Other study ID #: 201612747
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: University of Iowa
• Contact: Catherine Fruehling, BA
• Phone: 3194678256
• Email: catherine-fruehling[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Radiation:
• pedCAT
Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.

Locations

Country	Name	City	State
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
J L Marsh	Orthopaedic Trauma Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the ankle joint space width	Tracking longitudinal changes in the 3D joint space width as seen in pedCAT imaging compared to baseline pedCAT imaging	18 months
Secondary	Change in ankle pain	Subjective measure of foot and ankle pain gathered by patient reported outcomes questionnaires	18 months
Secondary	Change in ankle function	Subjective measure of foot and ankle function gathered by patient reported outcomes questionnaires	18 months