Pars Healing on MRI

University of Missouri (MU)

Status: Not yet enrolling

Conditions: Pars Interarticularis Stress Fracture; Pars Interarticularis Stress Injury

Treatments: Device: MRI

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07215845

2127781

Details and patient eligibility

About

The goal of this clinical trial is to learn more about the natural healing process of pars stress injuries in adolescents and young adults by documenting bony bridging across stress fractures using Magnetic Resonance Imaging (MRI). It is hypothesized that many of these injuries can and will heal with appropriate rest and rehabilitation. Long-term, it is hoped that follow-up MRI exams can help guide clinical management by visualizing the healing and allowing individuals to return to play after bony bridging has occurred.

Participants will be asked to undergo serial MRI scans over the course of a 12-month period and answer a brief questionnaire at each visit.

Full description

There is not a current, well-established standard of care (SoC) for initial diagnosis or follow-up imaging worldwide and these injuries are likely underdiagnosed. Some practices use conventional Magnetic Resonance Imaging (MRI) sequences which can be challenging to interpret, and the patient may undergo repeat testing or alternative imaging including Computed Tomography (CT), bone scans, or repeat MRIs (the former two of which can be high radiation and not optimal at the young age group).

Enrollment: 40 estimated patients

Sex: All

Ages: 12 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 12-30 years old
• Symptoms of back pain at the time of enrollment
• Clinical imaging demonstrating pars stress interarticularis injury or pars interarticularis defect

Exclusion criteria

• Prior lumbar surgery
• 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
• Any patient-related factors that compromised quality on the initial diagnostic scan (patient motion, ascites fluid, difficulty with positioning during the scan)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Test Group

Experimental group

Description:

Participants will receive serial MRIs over the course of 12-months at 2-, 4-, 6-, and 12 month intervals. This group's images will be used to help guide their clinical care outcomes.

Treatment:

Device: MRI

Control Group

Other group

Description:

Participants will receive serial MRIs over the course of 12-months at 2-, 4-, 6-, and 12 month intervals. This group's images will NOT be used to help guide their clinical care outcomes for the 2-, 4-, and 6-month images. However, the 12-month images may be used to guide clinical care outcomes.

Treatment:

Device: MRI