Pars Healing on MRI

NCT07215845 | Recruiting FDA Device

• 1 other identifier: 2127781
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pars Interarticularis Stress Fracture; Pars Interarticularis Stress Injury

Keywords

MRI; Pars Interarticularis Stress Fracture; Pars Interarticularis Stress Injury; Pars

Outcome Measures

Primary Outcomes (1)

• Pars Stress Injury Healing

  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.

  From enrollment to 12 months (4 total research scans at 2 months, 4 months, 6 months, and 12 months post initial scan)

Study Arms (2)

Test Group

EXPERIMENTAL

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.

Device: MRI

Control Group

OTHER

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.

Device: MRI

Interventions

MRI DEVICE

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.

Control Group; Test Group

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• GE Healthcare: collaborator

Study Sites (1)

University of Missouri - Columbia

Columbia, Missouri, 65212, United States

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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. Epub 2021 Jan 14.

  PMID: 33443599 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Study Officials

• Lauren Pringle, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica N Call

CONTACT

573-882-0515; jccfx@health.missouri.edu

Jenn Cornelius-Green

CONTACT

573-884-5483; corneliusj@health.missouri.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 14, 2025
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)