Pars Healing on MRI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI.
- Who it may be relevant to
- Registry conditions: Pars Interarticularis Stress Fracture, Pars Interarticularis Stress Injury. Basic parameters: 12 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pars Healing on oZTEo MRI
Overview
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).
Interventions
- 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.
Primary outcome measures
- 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)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- University of Missouri - Columbia — Columbia
Publications
- Aydingoz U, Yildiz AE, Ergen FB. Zero Echo Time Musculoskeletal MRI: Technique, Optimization, Applications, and Pitfalls. Radiographics. 2022 Sep-Oct;42(5):1398-1414. doi: 10.1148/rg.220029. Epub 2022 Jul 29. PMID 35904982
- Watura C, Mitchell AWM, Fahy D, Houghton J, Kang S, Lee JC. T1-VIBE and STIR MRI of lumbar pars interarticularis injuries in elite athletes: fracture characterisation and potential prognostic indicators. Skeletal Radiol. 2024 Mar;53(3):489-497. doi: 10.1007/s00256-023-04437-x. Epub 2023 Aug 31. PMID 37650925
- Ang EC, Robertson AF, Malara FA, O'Shea T, Roebert JK, Schneider ME, Rotstein AH. Diagnostic accuracy of 3-T magnetic resonance imaging with 3D T1 VIBE versus computer tomography in pars stress fracture of the lumbar spine. Skeletal Radiol. 2016 Nov;45(11):1533-40. doi: 10.1007/s00256-016-2475-7. Epub 2016 Sep 10. PMID 27614965
- Schwaiger BJ, Schneider C, Kronthaler S, Gassert FT, Bohm C, Pfeiffer D, Baum T, Kirschke JS, Karampinos DC, Makowski MR, Woertler K, Wurm M, Gersing AS. CT-like images based on T1 spoiled gradient-echo and ultra-short echo time MRI sequences for the assessment of vertebral fractures and degenerative bone changes of the spine. Eur Radiol. 2021 Jul;31(7):4680-4689. doi: 10.1007/s00330-020-07597-9. PMID 33443599
- Standaert CJ. Spondylolysis in the adolescent athlete. Clin J Sport Med. 2002 Mar;12(2):119-22. doi: 10.1097/00042752-200203000-00009. No abstract available. PMID 11953559
- Vij N, Naron I, Tolson H, Rezayev A, Kaye AD, Viswanath O, Urits I. Back pain in adolescent athletes: a narrative review. Orthop Rev (Pavia). 2022 Aug 5;14(3):37097. doi: 10.52965/001c.37097. eCollection 2022. PMID 35936806
- Murphy KP, Sanders C, Rabatin AE. Evaluation and Treatment of the Child with Acute Back Pain. Pediatr Clin North Am. 2023 Jun;70(3):545-574. doi: 10.1016/j.pcl.2023.01.013. Epub 2023 Mar 21. PMID 37121642
Identifiers
NCT: NCT07215845 · 2127781