Painful Post-Operative Hip Study

NCT07066709 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 4 other identifiers: 2025-0271A536110SMPH/ORTHO&REHAB/ORTHOProtocol Version 6/6/2025
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unilateral Hip Arthroscopy

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

Revision hip arthroscopy

EXPERIMENTAL

Participants will have undergone a revision hip arthroscopy and will have a FDG PET/MRI

Combination Product: FDG PET/MRI

Interventions

FDG PET/MRI COMBINATION_PRODUCT

Participants will undergo an FDG PET/MRI

Revision hip arthroscopy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arthroscopy Association of North America: collaborator
• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

RECRUITING

Study Officials

• Andrea Spiker, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amie Armstrong

CONTACT

608-262-9790; armstrong@ortho.wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 15, 2025
• Study Start: January 21, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)