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| ID | Type | Description | Link |
|---|---|---|---|
| A536110 | Other Identifier | UW Madison | |
| SMPH/ORTHO&REHAB/ORTHO | Other Identifier | UW Madison | |
| Protocol Version 6/6/2025 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Arthroscopy Association of North America | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Revision hip arthroscopy | Experimental | Participants will have undergone a revision hip arthroscopy and will have a FDG PET/MRI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDG PET/MRI | Combination Product | Participants will undergo an FDG PET/MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in number of lesions | Images will be taken using FDG PET/MRI to identify the number of lesions in the hip. | Baseline to 12 months |
| Change in size of lesions | Images will be taken using FDG PET/MRI to identify the size of the lesions in the hip. | Baseline to 12 months |
| Change in location of lesions | Images will be taken using FDG PET/MRI to identify the location of the lesions in the hip. | Baseline to 12 months |
| Change in pain symptoms | Participants will self-report pain level of 0-10, with 0 indicating no pain and 10 being the worst pain imaginable. | Baseline to 12 months |
| Change in PROMIs Global Health score | 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. | Baseline to 12 months |
| Change in Hip Outcome Score (HOS) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amie Armstrong | Contact | 608-262-9790 | armstrong@ortho.wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Spiker, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin - Madison | Recruiting | Madison | Wisconsin | 53705 | United States |
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| Baseline to 12 months |
| Change in Modified Harris Hip Score (mHHS) | 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. | Baseline to 12 months |
| Change in International Hip Outcome Tool score (iHOT) | 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. | Baseline to 12 months |