Painful Post-Operative Hip Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Unilateral Hip Arthroscopy
• Intervention / Treatment: Combination product: FDG PET/MRI

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amie Armstrong; Phone Number: 608-262-9790; Email: armstrong@ortho.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin - Madison
      • Contact: Amie Armstrong; Email: armstrong@ortho.wisc.edu
      • Principal Investigator: Andrea Spiker, MD
      • Sub-Investigator: Sandip Biswal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Revision hip arthroscopy; Participants will have undergone a revision hip arthroscopy and will have a FDG PET/MRI	Combination product: FDG PET/MRI; Participants will undergo an FDG PET/MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Arthroscopy Association of North America
• Investigators: Principal Investigator: Andrea Spiker, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: July 3, 2025
• First Submitted That Met QC Criteria: July 3, 2025
• First Posted (Actual): July 15, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-0271; A536110 (Other Identifier: UW Madison); SMPH/ORTHO&REHAB/ORTHO (Other Identifier: UW Madison); Protocol Version 6/6/2025 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No