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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Palo Alto Veterans Institute for Research
Study ID
NCT05700682
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
25 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Shoulder/Hip/Knee Embolization with Embozene Microspheres — DEVICE
    Fluoroscopically-guided arterial embolization of synovitis in the painful shoulder, hip or knee.

Study Details

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.

Key Dates

Start date
Jul 15, 2023
Status verified
Aug 2025
Primary completion
Mar 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Primary Clinical Outcome (Hip and Knee, Therapeutic Arm Only) [ Time Frame: Score obtained at follow-up visit 6 months after intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Palo Alto Healthcare SystemPalo AltoCalifornia94304
Eric Bultman, MD/PhD
[email protected]
650-493-5000
Sirish Kishore, MD
[email protected]
Sirish Kishore, MD (PRINCIPAL_INVESTIGATOR)
Eric Bultman, MD/PhD (PRINCIPAL_INVESTIGATOR)

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