University of Missouri - Columbia
Columbia, Missouri, 65212, United States
Location status: Recruiting
Location contact
Hailey N Schlaffer
CONTACT
Kim Ray
CONTACT
Lauren Pringle, MD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT07215845
Pars Healing on MRI
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
12 year–30 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
MRI
DeviceReader confidence using standard lumbar MRI techniques on diagnosing pars stress injuries will be compared to advanced techniques. Additionally, various software/MRI sequences will be tested to evaluate image quality and to improve resolution compared to institution pars MRI scan protocols.
Primary outcomes
-
Pars Stress Injury Healing
Time frame: From enrollment to 12 months (4 total research scans at 2 months, 4 months, 6 months, and 12 months post initial scan)
Stress injuries (fracture line and/or bone marrow edema) identified prior to study enrollment via initial clinical MRIs will be followed over serial research MRIs at 2 months, 4 months, 6 months, and 12 months after initial clinical MRI was completed. At each MRI, the fracture morphology (incomplete vs complete), bony bridging across any fracture line previously seen, amount of sclerosis, and presence of bone marrow edema will be described to assess degree of injury healing. Patient questionnaires including questions on pain scores will also be administered at the time of the research MRI scans.
Study contacts
Contact information is provided by the study sponsor or research team.
Hailey N Schlaffer
CONTACT
Kim Ray
CONTACT
Sponsors and collaborators
Lead sponsor
University of Missouri-Columbia
Other
Collaborators
- GE Healthcare
Registry information
Official study title
Pars Healing on oZTEo MRI
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Oct 14, 2025
- Registry last updated
- Jul 22, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.