Identifying and Managing Pain Generators in Patients With Persistent Post-hip Arthroscopy Pain Using FDG PET/MRI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in number of lesions
研究概览
简要总结
The goal of this clinical trial is to learn if the hips of people who undergo revision hip arthroscopy look different from the hips of people whose hip pain is resolved with the first hip arthroscopy and of people who choose the steroid injection for pain management.
Participants will complete one PET/MRI scan.
详细描述
Hip arthroscopy utilization has increased significantly and, as such, people are now dealing with an increase in hip arthroscopy failures. In many cases, a failed hip arthroscopy is treated with a revision hip arthroscopy versus conversion to a total hip replacement, but these procedures may not adequately address the etiology of hip pain in the setting of a failed hip arthroscopy. Physicians need better diagnostic tools to appropriately diagnose post- hip arthroscopy hip pain, so that they can offer the appropriate treatment. The advent of FDG PET/MRI offers a highly sensitive imaging method that detects areas of abnormal inflammation. The sensitivity of this method exceeds that of other imaging modalities (e.g., MRI alone) and gives physicians the best possible chance of detecting abnormal inflammatory or hypermetabolic pathology. The ability to better diagnose pain sources around the articular joint with this unique approach has not yet been explored in the post-arthroscopic hip.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-45
- •History of unilateral hip arthroscopy
- •Does not have evidence of fracture, infection, or malignancy at 6 months post-hip arthroscopy
- •Does not have evidence of depression or other major mental health conditions before the index hip arthroscopy
- •Does not have persistent pain that requires opioid use, or does not have a history of opioid abuse
- •Does not have any comorbidity results in systemic disease limiting function (ASA physical status classification >3)
- •Not currently pregnant
- •Presents with persistent pain (≥4/10 on NRS) for at least 6 months post-hip arthroscopy
- •Undergo a revision hip arthroscopy with no surgical history on the contralateral limb
排除标准
- •No unilateral hip arthroscopy
- •Evidence of fracture, infection, or malignancy at 6 months post-hip arthroscopy
- •Evidence of depression or other major mental health conditions before the index hip arthroscopy
- •Has persistent pain that requires opioid use, or has a history of opioid abuse
- •Has any comorbidity results in systemic disease limiting function (ASA physical status classification <3)
- •Currently pregnant
研究组 & 干预措施
Revision hip arthroscopy
Participants will have undergone a revision hip arthroscopy and will have a FDG PET/MRI
干预措施: FDG PET/MRI (Combination Product)
结局指标
主要结局
Change in number of lesions
时间窗: Baseline to 12 months
Images will be taken using FDG PET/MRI to identify the number of lesions in the hip.
Change in size of lesions
时间窗: Baseline to 12 months
Images will be taken using FDG PET/MRI to identify the size of the lesions in the hip.
Change in location of lesions
时间窗: Baseline to 12 months
Images will be taken using FDG PET/MRI to identify the location of the lesions in the hip.
Change in pain symptoms
时间窗: Baseline to 12 months
Participants will self-report pain level of 0-10, with 0 indicating no pain and 10 being the worst pain imaginable.
Change in PROMIs Global Health score
时间窗: Baseline to 12 months
Global Health is a participant-reported outcome measure that assesses an individual's overall physical and mental health, including their perceptions of general health. It comprises 10 items, with four items assessing Global Physical Health and four assessing Global Mental Health, all based on five core PROMIS domains: physical function, pain, fatigue, emotional distress, and social health. The scores, ranging from 0 to 20, represent the individual's perception of their health, with lower scores indicating greater impairment.
Change in Hip Outcome Score (HOS)
时间窗: Baseline to 12 months
The HOS is interpreted by evaluating scores on two subscales: Activities of Daily Living (ADL) and Sports. Each subscale is scored out of 100, with higher scores indicating better function. A score of 100 means no difficulty, while 0 indicates significant issues. Each item within the subscales is scored on a scale of 0 to 4, where 0 means "unable to do" and 4 means "no difficulty." The individual item scores are summed and then converted to a 0-100 scale.
Change in Modified Harris Hip Score (mHHS)
时间窗: Baseline to 12 months
The mHHS is interpreted based on a 0-100 scale, with higher scores indicating better hip function. Scores below 70 are considered poor, 70-79 fair, 80-89 good, and 90-100 excellent. The mHHS focuses on patient-reported pain and function.
Change in International Hip Outcome Tool score (iHOT)
时间窗: Baseline to 12 months
The iHOT is a questionnaire used to assess participant-reported outcomes related to hip conditions. It evaluates various aspects of hip health, including symptoms, functional limitations, sports and recreational activities, and social/emotional well-being. Higher scores on the iHOT generally indicate better hip function and quality of life. The iHOT-33 has 33 questions, each scored on a 100-point visual analog scale, with 0 representing the worst possible quality of life and 100 representing the best.
次要结局
未报告次要终点