Painful Post-Operative Hip Study

Официальное название

Identifying and Managing Pain Generators in Patients With Persistent Post-hip Arthroscopy Pain Using FDG PET/MRI

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт FDG PET/MRI
  Participants will undergo an FDG PET/MRI

Первичные конечные точки

• Change in number of lesions [Срок оценки: Baseline to 12 months]
• Change in size of lesions [Срок оценки: Baseline to 12 months]
• Change in location of lesions [Срок оценки: Baseline to 12 months]
• Change in pain symptoms [Срок оценки: Baseline to 12 months]
• Change in PROMIs Global Health score [Срок оценки: Baseline to 12 months]
• Change in Hip Outcome Score (HOS) [Срок оценки: Baseline to 12 months]
• Change in Modified Harris Hip Score (mHHS) [Срок оценки: Baseline to 12 months]
• Change in International Hip Outcome Tool score (iHOT) [Срок оценки: Baseline to 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Wisconsin - Madison — Madison

Идентификаторы

NCT: NCT07066709 · 2025-0271 · A536110 · SMPH/ORTHO&REHAB/ORTHO · Protocol Version 6/6/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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