Pars Healing on oZTEo MRI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pars Stress Injury Healing
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12-30 years old
- •Symptoms of back pain at the time of enrollment
- •Clinical imaging demonstrating pars stress interarticularis injury or pars interarticularis defect
排除标准
- •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)
研究组 & 干预措施
Test Group
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.
干预措施: MRI (Device)
Control Group
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.
干预措施: MRI (Device)
结局指标
主要结局
Pars Stress Injury Healing
时间窗: 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.
次要结局
未报告次要终点
研究者
Lauren Pringle
Assistant Professor
University of Missouri-Columbia