Pars Interarticularis Stress FractureNCT07215845
Pars Healing on MRI
A study testing MRI in people with Pars Interarticularis Stress Fracture and Pars Interarticularis Stress Injury, run by University of Missouri-Columbia at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Pars Interarticularis Stress Fracture, Pars Interarticularis Stress Injury
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12-30 years old
- Symptoms of back pain at the time of enrollment
- Clinical imaging demonstrating pars stress interarticularis injury or pars interarticularis defect
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri - Columbia
Columbia, Missouri, 65212
Hailey N Schlaffer, 573-882-0515, hs2c8@umsystem.edu
Kim Ray, 573-882-0515, raykk@health.missouri.edu
About this study
Official title: Pars Healing on oZTEo 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.
Read the 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).
- Being tested
- MRI
- Keywords
- MRI, Pars Interarticularis Stress Fracture, Pars Interarticularis Stress Injury, Pars
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 12 months (4 total research scans at 2 months, 4 months, 6 months, and 12 months post initial scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start12 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pars Interarticularis Stress FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Principal investigator, Lauren Pringle, University of Missouri-Columbia
- Investigators
- Lauren Pringle, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215845
- Sponsor's protocol ID
- 2127781
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: By signing the consent form, participants will be providing consent to the study team for their information to be shared with other researchers without obtaining their consent again. If/when data is shared with other researchers outside of the study, individual participant data will be de-identified as to not share the identity of participants. The IDP to be shared would be participant's MRI images and answers to study questionnaires.
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.
PubMed 35904982Watura 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.
PubMed 37650925Ang 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.
PubMed 27614965Schwaiger 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.
PubMed 33443599Standaert 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.
PubMed 11953559Vij 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.
PubMed 35936806Murphy 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.
PubMed 37121642
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pars Healing on oZTEo MRI
- ClinicalTrials.gov ID
- NCT07215845
- Acronym / sponsor ID
- 2127781
- Keywords
- MRI, Pars Interarticularis Stress Fracture, Pars Interarticularis Stress Injury, Pars
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: MRIParticipants 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. |
| Control Group | Other | Device: MRIParticipants 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. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 12-30 years old
- Symptoms of back pain at the time of enrollment
- Clinical imaging demonstrating pars stress interarticularis injury or pars interarticularis defect
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIReader 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. | Device | Control Group, Test Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 35904982Aydingoz 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.
- Background: PubMed 37650925Watura 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.
- Background: PubMed 27614965Ang 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.
- Background: PubMed 33443599Schwaiger 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.
- Background: PubMed 11953559Standaert 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.
- Background: PubMed 35936806Vij 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.
- Background: PubMed 37121642Murphy 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.
- Individual participant dataSharing planned: Yes. By signing the consent form, participants will be providing consent to the study team for their information to be shared with other researchers without obtaining their consent again. If/when data is shared with other researchers outside of the study, individual participant data will be de-identified as to not share the identity of participants. The IDP to be shared would be participant's MRI images and answers to study questionnaires.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Pringle, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Pars Interarticularis Stress Fracture and Pars Interarticularis Stress Injury, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hailey N Schlaffer (573-882-0515, hs2c8@umsystem.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07215845, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.