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Recruiting NCT07066709

Painful Post-Operative Hip Study

Phase II Interventional Unilateral Hip Arthroscopy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FDG PET/MRI.
Who it may be relevant to
Registry conditions: Unilateral Hip Arthroscopy. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Combination product FDG PET/MRI
    Participants will undergo an FDG PET/MRI

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Wisconsin - Madison — Madison

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗