MRI for Spondylolysis

JN
JC
Overseen ByJenn Cornelius-Green
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Missouri-Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the healing of pars stress injuries (tiny fractures in the spine) in young people using MRI scans (Magnetic Resonance Imaging). The aim is to determine if these injuries can heal with proper rest and rehabilitation and to track the healing process over a year. Participants will undergo several MRI scans to help understand natural bone healing, which could guide safe return to activities. The trial seeks individuals aged 12-30 who currently experience back pain and have been diagnosed with a specific type of spinal injury. As an unphased trial, it offers participants the chance to contribute to valuable research that could improve future treatment guidelines for spinal injuries.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that MRI is safe for adolescents and young adults?

Research shows that Magnetic Resonance Imaging (MRI) is a safe and comfortable method for detecting stress injuries in the spine. Studies have found that MRI effectively identifies pars injuries, which are tiny fractures in the spine. This capability helps doctors detect these injuries when other scans might miss them.

Unlike some other imaging methods, MRI does not use radiation, enhancing its safety. Although about 25% of MRI scans might be unnecessary, they cause no harm. Overall, MRI remains a safe choice for patients needing spine imaging.12345

Why are researchers excited about this trial?

Researchers are excited about using MRI for spondylolysis because it offers a non-invasive way to potentially improve patient outcomes. Unlike traditional methods, which may rely on static imaging like X-rays or CT scans, MRI provides detailed, dynamic images that can track changes over time. This method could lead to more personalized and timely treatment decisions, especially in the test group where MRI results actively guide clinical care. By offering a clearer picture of how the condition progresses, MRI might help tailor treatments more effectively, addressing the specific needs of each patient.

What evidence suggests that MRI is effective for guiding the healing process of spondylolysis?

Research has shown that MRI, or magnetic resonance imaging, excels at detecting early signs of spondylolysis, a type of stress fracture in the spine. MRI can identify these fractures even when other scans, such as CT scans, might miss them. Early detection is crucial as it allows doctors to treat the injury before it worsens. In this trial, participants in both the test and control groups will receive serial MRIs over 12 months. The test group's images will guide their clinical care outcomes, while the control group's images will not influence clinical care decisions until the 12-month mark. Studies also indicate that MRI effectively assesses both damage and changes in the spine. Overall, MRI is a powerful tool for diagnosing and managing spondylolysis, as it clearly shows the injury and helps track the healing process.16789

Who Is on the Research Team?

LP

Lauren Pringle, MD

Principal Investigator

University of Missouri-Columbia

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults with pars stress injuries, which are fractures in the spine. Participants will need to undergo multiple MRI scans over a year and answer questionnaires during their visits.

Inclusion Criteria

I am between 12 and 30 years old.
I am experiencing back pain currently.
My scans show a stress injury or defect in my spine.

Exclusion Criteria

Any condition for which an MRI procedure is contraindicated (e.g., metallic material in the body such as pacemakers, metallic clips, etc.)
Pregnancy
Likelihood of claustrophobia
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo serial MRI scans and complete questionnaires at 2, 4, 6, and 12 months to document healing of pars stress injuries

12 months
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MRI
Trial Overview The study uses MRI scans to observe how well the natural healing process works for spinal fractures without surgical intervention. The aim is to see if rest and rehabilitation allow these injuries to heal on their own.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Test GroupExperimental Treatment1 Intervention
Group II: Control GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials
387
Recruited
629,000+

GE Healthcare

Industry Sponsor

Trials
307
Recruited
634,000+
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Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

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Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/24978120/
Use of magnetic resonance imaging in the evaluation ...MRI was effective in identifying 36 pars lesions. MRI identified 11 lesions in 9 patients with negative CT. Seven of these lesions were stress reactions (grade ...
Clinical characteristics of early-stage lumbar spondylolysis ...... magnetic resonance imaging (MRI) is more effective for the early detection of spondylolysis [11]. Recent studies have advocated MRI over single-photon ...
LUMBAR SPONDYLOLYSIS: ARE ANCILLARY ...The MR images of 88 patients (41 male, 47 female; 14-80 years old) diagnosed with lumbar spondylolysis at 90 levels were retrospectively ...
Spondylolysis | Published in Orthopedic ReviewsMRI is also beneficial in assessment of both pathologic and morphologic abnormalities, although its efficacy in identification of morphologic ...
Unilateral Lumbar Spondylolysis on Radiography and MRIOBJECTIVE. The objective of our study was to retrospectively compare the radiography and MRI findings of unilateral spondylolysis in the upper lumbar ...
Overview of Radiological Classification Systems for Pars ...This article reviews the current imaging recommendations for diagnosing and grading pars stress injuries and spondylolysis before proposal of a novel ...
The Prevalence of Spondylolysis and the Diagnostic...When MRI has been compared to SPECT, with the latter used as the gold standard, the sensitivity of MRI in diagnosing spondylolysis is 80% (25). In light of ...
Deep-Learning-Aided Evaluation of Spondylolysis Imaged ...Isthmic spondylolysis results in fracture of pars interarticularis of the lumbar spine, found in as many as half of adolescent athletes with ...
Appropriateness of magnetic resonance imaging of the ...25.3% of MRI lumbar spine performed were inappropriate based on the ACR criteria. Moreover, there were no critical findings in this group.
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