Osteoarthritis, KneeMRINCT05700682
Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee
An observational study of Osteoarthritis, Knee and Osteoarthritis, Hip, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
In this work the investigators will study the relationship between chronic musculoskeletal pain and abnormal blood flow (neovascularity) around the shoulder, hip and knee. Veterans with as history of chronic shoulder, hip or knee pain and mild/moderate joint degenerative changes will be potential study subjects. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteo Arthritis Shoulders
- What is being tested?
- Shoulder/Hip/Knee Embolization with Embozene Microspheres
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2023to 1 Aug 2026
- Phase
- Observational
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be veterans eligible for care at the VA. Anticipated age range is 25-80. Gender will be predominantly male (approximately 90%), concordant with demographic information of the VA population. Pregnant women, children, vulnerable subjects, study personnel and students will not be eligible for enrollment.
Who may be able to join
- Participants must be Veterans who receive care in the VA system.
- Participants must have a history of chronic pain of the shoulder, hip or knee for at least 1 year.
- Participants must have mild to moderate degenerative changes of the painful joint as depicted on prior imaging (X-ray, CT or MRI).
- Participants must have undergone at least one failed primary treatment for their chronic pain (e.g. physical therapy, NSAIDs, steroid injection).
- Participants must have an MRI of their painful joint (shoulder, hip or knee) ordered by a clinical provider.
- Participants must have enrolled in the Diagnostic Arm of the study and must have undergone perfusion MR imaging of their painful joint.
- Participants must have evidence of peri-articular hypervascularity on their perfusion MR exams. This will be determined by the study PIs.
Who cannot join
- Acute injury in the last 12 weeks.
- Age under 25.
- Severe degenerative changes of painful joint (shoulder, hip or knee).
- History of arthroplasty or metallic implant within the painful joint.
- Severe gadolinium contrast allergy.
- Severe renal disease or ongoing dialysis.
Show all 18Show fewer
- History of malignancy with life expectancy of less than one year, or malignancy with known bone metastasis.
- Current pregnancy.
- Formal diagnosis of cognitive impairment.
- Severe iodinated contrast allergy.
- Severe coronary or peripheral arterial disease.
- Coagulopathy.
- Uncontrolled type 2 diabetes or diabetic neuropathy.
- History of seizures or other severe complication from conscious sedation.
- Prior upper or lower extremity arterial bypass.
- Ongoing participation in another interventional (therapeutic) trial for chronic joint pain.
- Lack of peri-articular hypervascularity on initial perfusion MRI.
- All exclusion criteria for the Diagnostic Arm.
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
VA Palo Alto Healthcare System
Palo Alto, California, 94304
Eric Bultman, MD/PhD, 650-493-5000 ext. 61502, eric.bultman1@va.gov
Sirish Kishore, MD, sirish.kishore@va.gov
About this study
Official title: Perfusion MRI-targeted Joint Embolization to Diagnose and Treat Neovascularity Associated With Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee: A Prospective Cohort Study
In this work the investigators will study the relationship between chronic musculoskeletal pain and abnormal blood flow (neovascularity) around the shoulder, hip and knee. Veterans with as history of chronic shoulder, hip or knee pain and mild/moderate joint degenerative changes will be potential study subjects. Blood flow around joints will be evaluated using perfusion magnetic resonance imaging (MRI). Participants with demonstrably abnormal blood flow around their painful joint will be eligible for enrollment in a pilot study of joint embolization to treat their pain. Participants who choose to not undergo treatment will be re-assessed with MRI after one year to characterize the natural history of joint neovascularity and its relationship to pain.
Read the detailed description
- Joint MRI (shoulder, hip, knee) is ordered by a clinical provider due to ongoing/chronic joint pain. At the time of MR exam protocoling, investigators review prior imaging and determine that the patient has mild-moderate osteoarthritis. Patient is identified as a potential participant and is sent a letter by physical mail or e-mail (signed by PIs) discussing the research project. Subsequently, the clinical research coordinator reaches out to the potential participant by phone 7-14 days before the date of the MR exam to assess interest in the study.
- Participant is interested and enrolls in the Diagnostic Arm of the study. Upon enrollment, the participant will undergo perfusion MRI and cartilage parameter mapping at the time of the initial MR exam (a 15-minute "add on" scan with Multihance intravenous contrast at the end of the standard clinical MRI). The participant will also complete a WOMAC (knee/hip) or WORC (shoulder) survey to document the baseline characteristics of their pain.
- If there is NO neovascularity on the perfusion MRI, the participant will remain in the Diagnostic Arm of the study. Participants who remain in the Diagnostic Arm will undergo follow-up WOMAC surveys at 6 months / 1 year; and a research perfusion MR at one year. Follow-up data from the 1-year visit will represent the primary clinical and imaging endpoints of the Diagnostic Arm.
- If neovascularity is present, the participant will be offered enrollment into the Therapeutic Arm. Participants not interested in the Therapeutic Arm will remain in the Diagnostic Arm.
- Participants who elect to enroll in the Therapeutic Arm of the study are referred to the study investigators, who will screen for exclusion criteria. Importantly, if the participant has risk factors for or confirmed peripheral arterial disease (PAD), they must undergo CT angiography of the relevant anatomy (abdomen/pelvis with or without lower extremity runoff). If the participant does not meet any exclusion criteria, they will be scheduled for embolization therapy of their painful joint (shoulder, hip or knee). The participant will undergo embolization under fluoroscopic guidance using Embozene microspheres. Briefly, the relevant arterial vessels supplying the joint of interest will be accessed with an arterial catheter. The presence of abnormal peri-articular vessels seen on MRI will be confirmed during fluoroscopic imaging with injection of contrast material (Omnipaque). These abnormal vessels will then be embolized via careful injection of bland embolic particles (Embozene microspheres). After embolization, participant will attend one clinic follow-up visit at 2 weeks to screen for side effects or complications. The participant will be surveyed for their symptoms (WOMAC/WORC) at 1, 3, 6 and 12-months post-treatment. They will undergo research MR exams perfusion and cartilage parameter mapping at 3- and 12-months post-treatment.
- Recruitment will occur over 1.5 years. Follow-up in both Arms will occur over 1 year. After completion of the study, the investigators anticipate approximately 3-4 months will be required for data analysis and manuscript preparation. Total study duration will therefore be 2.5 to 3 years.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteo Arthritis Shoulders, Synovitis of Knee, Synovitis/Tenosynovitis - Hip, Synovitis
- Being tested
- Shoulder/Hip/Knee Embolization with Embozene Microspheres
- Keywords
- joint, embolization, neovascularity, pain, knee, hip, shoulder
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Synovitis, Chronic Pain, Neovascularization, Pathologic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder/Hip/Knee Embolization with Embozene MicrospheresDevice
Fluoroscopically-guided arterial embolization of synovitis in the painful shoulder, hip or knee.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic | The investigators will target VA patients with clinically-ordered knee, hip and shoulder MRIs for recruitment (40 for each joint). Patients who elect to participate will undergo perfusion MRI add-on sequence at the end of their clinical MRI. Arterial-phase maximum intensity projection images from the perfusion MR data will be generated, and the presence of abnormal vascularity about each joint will be assessed by the study principal investigators. Participants who have focal or generalized peri-articular hypervascularity will be offered enrollment in the Therapeutic Arm of the study. Those participants who decline enrollment into the Therapeutic Arm, and those without significant peri-articular vascularity on perfusion MRI, will be asked to return for follow-up clinical and imaging visits so that the natural history of pain/imaging parameters in the absence of treatment can be evaluated. | |
| Therapeutic | Of 40 participants enrolled for each joint, the investigators anticipate 20 will choose to enroll in an embolization pilot study. Participants must have peri-articular hypervascularity on perfusion MRI and must have failed at least one first line therapy for their pain to be eligible.
Embolization will be performed as an outpatient procedure under conscious sedation. Further description of this procedure is available in the study protocol and literature. Technical success will be defined as selective embolization of at least one abnormal peri-articular artery.
After embolization, participants will return for clinical follow-up at 1, 3, 6 and 12 months with perfusion MRI performed at the 3- and 12-month visits. Clinical follow-up at 3, 6 and 12 months will consist only of surveys (WOMAC/WORC). Participants will be instructed to avoid additional treatments for their joint pain when possible, and if a second treatment is initiated to report it to the study investigators. Receives: Device: Shoulder/Hip/Knee Embolization with Embozene Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Clinical Outcome (Hip and Knee, Therapeutic Arm Only)
Composite WOMAC survey score
Measured: Score obtained at follow-up visit 6 months after intervention
Primary Clinical Outcome (Shoulder, Therapeutic Arm Only)
Composite WORC survey score
Measured: Score obtained at follow-up visit 6 months after intervention
Primary Imaging Outcome (Therapeutic Arm Only)
Quantitative perfusion parameters (Ktrans, mean transit time, fractional extracellular volume, time-to-peak)
Measured: Research MRI obtained 3 months after intervention
Secondary outcomes (4)
Secondary Clinical Outcome (Hip and Knee, Diagnostic Arm Only)
Composite WOMAC survey score
Measured: Score obtained at follow-up visit after 12 months
Secondary Clinical Outcome (Shoulder, Diagnostic Arm Only)
Composite WORC survey score
Measured: Score obtained at follow-up visit after 12 months
Secondary Imaging Outcome (Diagnostic Arm Only)
Quantitative perfusion parameters (Ktrans, mean transit time, fractional extracellular volume, time-to-peak)
Measured: Research MRI obtained after 12 months of follow-up
Secondary Imaging Outcome 2 (Diagnostic Arm Only)
Quantitative cartilage mapping parameters (T1rho, T2) in milliseconds averaged over manually segmented cartilage for each joint (shoulder, hip or knee)
Measured: Research MRI obtained after 12 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start15 Jul 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Principal investigator, Sirish Kishore, Palo Alto Veterans Institute for Research
- Investigators
- Sirish Kishore, MD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700682
- Sponsor's protocol ID
- KIS0001ARG
- Acronym
- MRI
- Status last verified
- Aug 2025
- First submitted
- 22 Dec 2022
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perfusion MRI-targeted Joint Embolization to Diagnose and Treat Neovascularity Associated With Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05700682
- Acronym / sponsor ID
- MRI / KIS0001ARG
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteo Arthritis Shoulders, Synovitis of Knee, Synovitis/Tenosynovitis - Hip, Synovitis
- Keywords
- joint, embolization, neovascularity, pain, knee, hip, shoulder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 26 Jan 2023 (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.
In this work the investigators will study the relationship between chronic musculoskeletal pain and abnormal blood flow (neovascularity) around the shoulder, hip and knee. Veterans with as history of chronic shoulder, hip or knee pain and mild/moderate joint degenerative changes will be potential study subjects. Blood flow around joints will be evaluated using perfusion magnetic resonance imaging (MRI). Participants with demonstrably abnormal blood flow around their painful joint will be eligible for enrollment in a pilot study of joint embolization to treat their pain. Participants who choose to not undergo treatment will be re-assessed with MRI after one year to characterize the natural history of joint neovascularity and its relationship to pain.
Detailed description
- Joint MRI (shoulder, hip, knee) is ordered by a clinical provider due to ongoing/chronic joint pain. At the time of MR exam protocoling, investigators review prior imaging and determine that the patient has mild-moderate osteoarthritis. Patient is identified as a potential participant and is sent a letter by physical mail or e-mail (signed by PIs) discussing the research project. Subsequently, the clinical research coordinator reaches out to the potential participant by phone 7-14 days before the date of the MR exam to assess interest in the study.
- Participant is interested and enrolls in the Diagnostic Arm of the study. Upon enrollment, the participant will undergo perfusion MRI and cartilage parameter mapping at the time of the initial MR exam (a 15-minute "add on" scan with Multihance intravenous contrast at the end of the standard clinical MRI). The participant will also complete a WOMAC (knee/hip) or WORC (shoulder) survey to document the baseline characteristics of their pain.
- If there is NO neovascularity on the perfusion MRI, the participant will remain in the Diagnostic Arm of the study. Participants who remain in the Diagnostic Arm will undergo follow-up WOMAC surveys at 6 months / 1 year; and a research perfusion MR at one year. Follow-up data from the 1-year visit will represent the primary clinical and imaging endpoints of the Diagnostic Arm.
- If neovascularity is present, the participant will be offered enrollment into the Therapeutic Arm. Participants not interested in the Therapeutic Arm will remain in the Diagnostic Arm.
- Participants who elect to enroll in the Therapeutic Arm of the study are referred to the study investigators, who will screen for exclusion criteria. Importantly, if the participant has risk factors for or confirmed peripheral arterial disease (PAD), they must undergo CT angiography of the relevant anatomy (abdomen/pelvis with or without lower extremity runoff). If the participant does not meet any exclusion criteria, they will be scheduled for embolization therapy of their painful joint (shoulder, hip or knee). The participant will undergo embolization under fluoroscopic guidance using Embozene microspheres. Briefly, the relevant arterial vessels supplying the joint of interest will be accessed with an arterial catheter. The presence of abnormal peri-articular vessels seen on MRI will be confirmed during fluoroscopic imaging with injection of contrast material (Omnipaque). These abnormal vessels will then be embolized via careful injection of bland embolic particles (Embozene microspheres). After embolization, participant will attend one clinic follow-up visit at 2 weeks to screen for side effects or complications. The participant will be surveyed for their symptoms (WOMAC/WORC) at 1, 3, 6 and 12-months post-treatment. They will undergo research MR exams perfusion and cartilage parameter mapping at 3- and 12-months post-treatment.
- Recruitment will occur over 1.5 years. Follow-up in both Arms will occur over 1 year. After completion of the study, the investigators anticipate approximately 3-4 months will be required for data analysis and manuscript preparation. Total study duration will therefore be 2.5 to 3 years.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic | – | –The investigators will target VA patients with clinically-ordered knee, hip and shoulder MRIs for recruitment (40 for each joint). Patients who elect to participate will undergo perfusion MRI add-on sequence at the end of their clinical MRI. Arterial-phase maximum intensity projection images from the perfusion MR data will be generated, and the presence of abnormal vascularity about each joint will be assessed by the study principal investigators. Participants who have focal or generalized peri-articular hypervascularity will be offered enrollment in the Therapeutic Arm of the study. Those participants who decline enrollment into the Therapeutic Arm, and those without significant peri-articular vascularity on perfusion MRI, will be asked to return for follow-up clinical and imaging visits so that the natural history of pain/imaging parameters in the absence of treatment can be evaluated. |
| Therapeutic | – | Device: Shoulder/Hip/Knee Embolization with Embozene MicrospheresOf 40 participants enrolled for each joint, the investigators anticipate 20 will choose to enroll in an embolization pilot study. Participants must have peri-articular hypervascularity on perfusion MRI and must have failed at least one first line therapy for their pain to be eligible. Embolization will be performed as an outpatient procedure under conscious sedation. Further description of this procedure is available in the study protocol and literature. Technical success will be defined as selective embolization of at least one abnormal peri-articular artery. After embolization, participants will return for clinical follow-up at 1, 3, 6 and 12 months with perfusion MRI performed at the 3- and 12-month visits. Clinical follow-up at 3, 6 and 12 months will consist only of surveys (WOMAC/WORC). Participants will be instructed to avoid additional treatments for their joint pain when possible, and if a second treatment is initiated to report it to the study investigators. |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be veterans eligible for care at the VA. Anticipated age range is 25-80. Gender will be predominantly male (approximately 90%), concordant with demographic information of the VA population. Pregnant women, children, vulnerable subjects, study personnel and students will not be eligible for enrollment.
Key inclusion criteria (7 listed)
- Participants must be Veterans who receive care in the VA system.
- Participants must have a history of chronic pain of the shoulder, hip or knee for at least 1 year.
- Participants must have mild to moderate degenerative changes of the painful joint as depicted on prior imaging (X-ray, CT or MRI).
- Participants must have undergone at least one failed primary treatment for their chronic pain (e.g. physical therapy, NSAIDs, steroid injection).
- Participants must have an MRI of their painful joint (shoulder, hip or knee) ordered by a clinical provider.
Key exclusion criteria (18 listed)
- Acute injury in the last 12 weeks.
- Age under 25.
- Severe degenerative changes of painful joint (shoulder, hip or knee).
- History of arthroplasty or metallic implant within the painful joint.
- Severe gadolinium contrast allergy.
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 |
|---|---|---|
| Shoulder/Hip/Knee Embolization with Embozene MicrospheresFluoroscopically-guided arterial embolization of synovitis in the painful shoulder, hip or knee. | Device | Therapeutic |
Primary outcome
Primary Clinical Outcome (Hip and Knee, Therapeutic Arm Only)
Time frame: Score obtained at follow-up visit 6 months after intervention
Composite WOMAC survey score
Primary Clinical Outcome (Shoulder, Therapeutic Arm Only)
Time frame: Score obtained at follow-up visit 6 months after intervention
Composite WORC survey score
Primary Imaging Outcome (Therapeutic Arm Only)
Time frame: Research MRI obtained 3 months after intervention
Quantitative perfusion parameters (Ktrans, mean transit time, fractional extracellular volume, time-to-peak)
4 secondary outcomes
Secondary Clinical Outcome (Hip and Knee, Diagnostic Arm Only)
Time frame: Score obtained at follow-up visit after 12 months
Secondary Clinical Outcome (Shoulder, Diagnostic Arm Only)
Time frame: Score obtained at follow-up visit after 12 months
Secondary Imaging Outcome (Diagnostic Arm Only)
Time frame: Research MRI obtained after 12 months of follow-up
Secondary Imaging Outcome 2 (Diagnostic Arm Only)
Time frame: Research MRI obtained after 12 months of follow-up
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 7 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Sirish Kishore, MD principal investigator
VA Palo Alto Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Osteoarthritis, Hip, run by Palo Alto Veterans Institute for Research 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 7 inclusion and 18 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 7 Aug 2025. 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.
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 Eric Bultman, MD, PhD (560-493-5000 ext. 61502, eric.bultman1@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Clinical Outcome (Hip and Knee, Therapeutic Arm Only) (time frame: Score obtained at follow-up visit 6 months after intervention). The study lists 3 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 7 Aug 2025.