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

NCT ID: NCT03809520

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2024-12-30

Brief Summary

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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

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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

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Orthopedic Disorder Trauma Ankle Fractures Post-traumatic Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Experimental: pedCAT

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

Group Type EXPERIMENTAL

pedCAT

Intervention Type RADIATION

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

Interventions

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pedCAT

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orthopaedic Trauma Association

OTHER

Sponsor Role collaborator

J L Marsh

OTHER

Sponsor Role lead

Responsible Party

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J L Marsh

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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J L Marsh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Catherine Fruehling, BA

Role: CONTACT

Phone: 3194678256

Email: [email protected]

Facility Contacts

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Catherine Fruehling, BA

Role: primary

Other Identifiers

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201612747

Identifier Type: -

Identifier Source: org_study_id