Pars Healing on MRI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-30
SponsorUniversity of Missouri-Columbia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
12-30 years old
Symptoms of back pain at the time of enrollment
Clinical imaging demonstrating pars stress interarticularis injury or pars interarticularis defect
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Test GroupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention
Trial outcomes
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.
Time frame
From enrollment to 12 months (4 total research scans at 2 months, 4 months, 6 months, and 12 months post initial scan)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Missouri-Columbia
Lead sponsor
GE Healthcare
Collaborator
Source ClinicalTrials.gov