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

Primary Purpose

Orthopedic Disorder, Trauma, Ankle Fractures

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pedCAT
Sponsored by
J L Marsh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Orthopedic Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Iowa Hospitals and ClinicsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: pedCAT

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in ankle pain
Subjective measure of foot and ankle pain gathered by patient reported outcomes questionnaires
Change in ankle function
Subjective measure of foot and ankle function gathered by patient reported outcomes questionnaires

Full Information

First Posted
December 20, 2018
Last Updated
May 10, 2023
Sponsor
J L Marsh
Collaborators
Orthopaedic Trauma Association
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1. Study Identification

Unique Protocol Identification Number
NCT03809520
Brief Title
An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA
Official Title
An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
J L Marsh
Collaborators
Orthopaedic Trauma Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder, Trauma, Ankle Fractures, Post-traumatic Osteoarthritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: pedCAT
Arm Type
Experimental
Arm Description
Subjects in this group will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury.
Intervention Type
Radiation
Intervention Name(s)
pedCAT
Intervention Description
Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
Primary Outcome Measure Information:
Title
Changes in the ankle joint space width
Description
Tracking longitudinal changes in the 3D joint space width as seen in pedCAT imaging compared to baseline pedCAT imaging
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in ankle pain
Description
Subjective measure of foot and ankle pain gathered by patient reported outcomes questionnaires
Time Frame
18 months
Title
Change in ankle function
Description
Subjective measure of foot and ankle function gathered by patient reported outcomes questionnaires
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Fruehling, BA
Phone
3194678256
Email
catherine-fruehling@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J L Marsh, MD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Fruehling, BA
Phone
319-467-8256
Email
catherine-fruehling@uiowa.edu
First Name & Middle Initial & Last Name & Degree
J L Marsh, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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