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

Recruiting

• Conditions: Pain, Chronic; Osteo Arthritis Shoulders; Osteoarthritis, Knee; Synovitis/Tenosynovitis - Hip; Osteoarthritis, Hip; Synovitis of Knee; Synovitis
• Interventions: Device: Shoulder/Hip/Knee Embolization with Embozene Microspheres

• Registration Number: NCT05700682
• Lead Sponsor: Palo Alto Veterans Institute for Research

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.

Detailed Description

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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 Timeline

• Study First Submitted: 2022-12-22
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-26
• Study Start: 2023-07-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Primary Completion: 2026-03-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Therapeutic	Shoulder/Hip/Knee Embolization with Embozene Microspheres	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 Measures

Name	Time	Method
Primary Clinical Outcome (Hip and Knee, Therapeutic Arm Only)	Score obtained at follow-up visit 6 months after intervention	Composite WOMAC survey score
Primary Clinical Outcome (Shoulder, Therapeutic Arm Only)	Score obtained at follow-up visit 6 months after intervention	Composite WORC survey score
Primary Imaging Outcome (Therapeutic Arm Only)	Research MRI obtained 3 months after intervention	Quantitative perfusion parameters (Ktrans, mean transit time, fractional extracellular volume, time-to-peak)

Secondary Outcome Measures

Name	Time	Method
Secondary Imaging Outcome (Diagnostic Arm Only)	Research MRI obtained after 12 months of follow-up	Quantitative perfusion parameters (Ktrans, mean transit time, fractional extracellular volume, time-to-peak)
Secondary Clinical Outcome (Hip and Knee, Diagnostic Arm Only)	Score obtained at follow-up visit after 12 months	Composite WOMAC survey score
Secondary Clinical Outcome (Shoulder, Diagnostic Arm Only)	Score obtained at follow-up visit after 12 months	Composite WORC survey score
Secondary Imaging Outcome 2 (Diagnostic Arm Only)	Research MRI obtained after 12 months of follow-up	Quantitative cartilage mapping parameters (T1rho, T2) in milliseconds averaged over manually segmented cartilage for each joint (shoulder, hip or knee)

Trial Locations

Locations (1)

VA Palo Alto Healthcare System; 🇺🇸 Palo Alto, California, United States