Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee

NCT05700682 | Recruiting FDA Device

• 1 other identifier: KIS0001ARG
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Osteo Arthritis Shoulders; Synovitis of Knee; Synovitis/Tenosynovitis - Hip; Synovitis; Pain, Chronic

Keywords

joint; embolization; neovascularity; pain; knee; hip; shoulder

Outcome Measures

Primary Outcomes (3)

• Primary Clinical Outcome (Hip and Knee, Therapeutic Arm Only)

  Composite WOMAC survey score

  Score obtained at follow-up visit 6 months after intervention

• Primary Clinical Outcome (Shoulder, Therapeutic Arm Only)

  Composite WORC survey score

  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)

  Research MRI obtained 3 months after intervention

Secondary Outcomes (4)

• Secondary Clinical Outcome (Hip and Knee, Diagnostic Arm Only)

  Score obtained at follow-up visit after 12 months

• Secondary Clinical Outcome (Shoulder, Diagnostic Arm Only)

  Score obtained at follow-up visit after 12 months

• Secondary Imaging Outcome (Diagnostic Arm Only)

  Research MRI obtained after 12 months of follow-up

• Secondary Imaging Outcome 2 (Diagnostic Arm Only)

  Research MRI obtained after 12 months of follow-up

Study Arms (2)

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.

Device: Shoulder/Hip/Knee Embolization with Embozene Microspheres

Interventions

Shoulder/Hip/Knee Embolization with Embozene Microspheres DEVICE

Fluoroscopically-guided arterial embolization of synovitis in the painful shoulder, hip or knee.

Therapeutic

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• Varian Medical Systems: collaborator

Study Sites (1)

VA Palo Alto Healthcare System

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Synovitis; Chronic Pain; Neovascularization, Pathologic; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metaplasia; Pathologic Processes

Study Officials

• Sirish Kishore, MD

  VA Palo Alto Health Care System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Bultman, MD, PhD

CONTACT

560-493-5000; eric.bultman1@va.gov

Sirish Kishore, MD

CONTACT

650-493-5000; sirish.kishore@va.gov

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 26, 2023
• Study Start: July 15, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)