Recruiting

NCT Number: NCT07066709

Painful Post-Operative Hip Study

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.

Recruiting

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Key information

Conditions

Unilateral Hip Arthroscopy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location status: Recruiting

Location contact

Amie Armstrong

CONTACT

[email protected]

Andrea Spiker, MD

PRINCIPAL_INVESTIGATOR

Sandip Biswal, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FDG PET/MRI

Combination Product

Participants will undergo an FDG PET/MRI

Primary outcomes

Change in number of lesions

Time frame: Baseline to 12 months

Images will be taken using FDG PET/MRI to identify the number of lesions in the hip.
Change in size of lesions

Time frame: Baseline to 12 months

Images will be taken using FDG PET/MRI to identify the size of the lesions in the hip.
Change in location of lesions

Time frame: Baseline to 12 months

Images will be taken using FDG PET/MRI to identify the location of the lesions in the hip.
Change in pain symptoms

Time frame: Baseline to 12 months

Participants will self-report pain level of 0-10, with 0 indicating no pain and 10 being the worst pain imaginable.
Change in PROMIs Global Health score

Time frame: Baseline to 12 months

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.
Change in Hip Outcome Score (HOS)

Time frame: Baseline to 12 months

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.
Change in Modified Harris Hip Score (mHHS)

Time frame: Baseline to 12 months

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.
Change in International Hip Outcome Tool score (iHOT)

Time frame: Baseline to 12 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amie Armstrong

CONTACT

[email protected]

608-262-9790

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

Arthroscopy Association of North America

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 15, 2025
Registry last updated: Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.