Unilateral Hip ArthroscopyPhase 2NCT07066709
Painful Post-Operative Hip Study
A Phase 2 study testing FDG PET/MRI in people with Unilateral Hip Arthroscopy, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Unilateral Hip Arthroscopy
- What is being tested?
- FDG PET/MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2026to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Amie Armstrong, armstrong@ortho.wisc.edu
Andrea Spiker, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Unilateral Hip Arthroscopy
- Being tested
- FDG PET/MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PET/MRICombination product
Participants will undergo an FDG PET/MRI
| Study group | Role | What they receive |
|---|---|---|
| Revision hip arthroscopy | Experimental | Participants will have undergone a revision hip arthroscopy and will have a FDG PET/MRI Receives: Combination Product: FDG PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of lesions
Images will be taken using FDG PET/MRI to identify the number of lesions in the hip.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start21 Jan 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Hip ArthroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Arthroscopy Association of North America
- Responsible party
- Sponsor
- Investigators
- Andrea Spiker, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066709
- Sponsor's protocol ID
- 2025-0271
- Other IDs
- A536110, SMPH/ORTHO&REHAB/ORTHO, Protocol Version 5/8/2026
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying and Managing Pain Generators in Patients With Persistent Post-hip Arthroscopy Pain Using FDG PET/MRI
- ClinicalTrials.gov ID
- NCT07066709
- Acronym / sponsor ID
- 2025-0271
- Conditions
- Unilateral Hip Arthroscopy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Arthroscopy Association of North America
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Revision hip arthroscopy | Experimental | Combination Product: FDG PET/MRIParticipants will have undergone a revision hip arthroscopy and will have a FDG PET/MRI |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDG PET/MRIParticipants will undergo an FDG PET/MRI | Combination product | Revision hip arthroscopy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Spiker, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FDG PET/MRI in people with Unilateral Hip Arthroscopy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amie Armstrong (608-262-9790, armstrong@ortho.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of lesions (time frame: Baseline to 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.