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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

Must not have

Individuals younger than 18 and older than 70

Women who are pregnant or planning on becoming pregnant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am between 18 and 70 years old.

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I am not pregnant and not planning to become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in the ankle joint space width

Secondary study objectives

Change in ankle function

Change in ankle pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met

Find a Location

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

33 Previous Clinical Trials

5,044 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.