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Advanced Imaging for Post-Traumatic Osteoarthritis

N/A
Recruiting
Led By J L Marsh, MD
Research Sponsored by J L Marsh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Indicated for operative treatment
Sustained an intra-articular fracture of the tibial plafond
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Study Summary

This trial will test a new CT system to see if it can detect joint degeneration and elevated contact stress more efficiently than other imaging modalities. The goal is to enable predictive models for osteoarthritis risk based on measures of post treatment contact stress.

Who is the study for?
This trial is for people aged 18-70 who need surgery after an ankle fracture involving the tibial plafond and can start treatment within 4 weeks of injury. Pregnant women or those planning pregnancy, and individuals outside this age range cannot participate.Check my eligibility
What is being tested?
The study is evaluating a new standing CT scanner called pedCAT that may detect early joint degeneration and stress in weight-bearing poses better than current methods. It aims to improve osteoarthritis risk prediction post-injury.See study design
What are the potential side effects?
Since the intervention involves imaging with a CT scanner, there are no direct side effects like with medications; however, there's exposure to low-dose radiation which carries minimal risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am recommended for surgery.
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I have had a fracture inside my ankle joint.
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I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in the ankle joint space width
Secondary outcome measures
Change in ankle function
Change in ankle pain

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: pedCATExperimental Treatment1 Intervention
Subjects in this group will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury.

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Who is running the clinical trial?

J L MarshLead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
1 Trials studying Osteoarthritis
5 Patients Enrolled for Osteoarthritis
Orthopaedic Trauma AssociationOTHER
32 Previous Clinical Trials
4,996 Total Patients Enrolled
J L Marsh, MD3.73 ReviewsPrincipal Investigator - University of Iowa
University of Iowa
5Patient Review
Dr. Marsh has been my go-to since 1993. They successfully mended my tibial plateau fracture with meniscus tear. I appreciated being kept in the loop regarding what they were doing and why. The results were perfect — minimal scarring. I had a second surgery 12 years later to remove the metal, and lastly in 2013 I had to have a knee replacement. I wouldn't go to anyone else.

Media Library

pedCAT Clinical Trial Eligibility Overview. Trial Name: NCT03809520 — N/A
Osteoarthritis Research Study Groups: Experimental: pedCAT
Osteoarthritis Clinical Trial 2023: pedCAT Highlights & Side Effects. Trial Name: NCT03809520 — N/A
pedCAT 2023 Treatment Timeline for Medical Study. Trial Name: NCT03809520 — N/A
~1 spots leftby Dec 2024
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