Trials / Recruiting
RecruitingNCT07215845
Pars Healing on MRI
Pars Healing on oZTEo MRI
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- University of Missouri-Columbia · Academic / Other
- Sex
- All
- Age
- 12 Years – 30 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MRI | Reader 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. |
Timeline
- Start date
- 2025-12-12
- Primary completion
- 2027-12-31
- Completion
- 2028-12-31
- First posted
- 2025-10-14
- Last updated
- 2026-03-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07215845. Inclusion in this directory is not an endorsement.