Osteoarthritis, Hip, Osteoarthritis, Knee, Osteo Arthritis Shoulders, Pain, Chronic, Synovitis, Synovitis of Knee, Synovitis/Tenosynovitis - Hip
Conditions
Keywords
joint, embolization, neovascularity, pain, knee, hip, shoulder
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.
Interventions
DEVICEShoulder/Hip/Knee Embolization with Embozene Microspheres
Fluoroscopically-guided arterial embolization of synovitis in the painful shoulder, hip or knee.
Sponsors
Varian Medical Systems
Palo Alto Veterans Institute for Research
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(Both Arms): 1. Participants must be Veterans who receive care in the VA system. 2. Participants must have a history of chronic pain of the shoulder, hip or knee for at least 1 year. 3. Participants must have mild to moderate degenerative changes of the painful joint as depicted on prior imaging (X-ray, CT or MRI). 4. Participants must have undergone at least one failed primary treatment for their chronic pain (e.g. physical therapy, NSAIDs, steroid injection). 5. Participants must have an MRI of their painful joint (shoulder, hip or knee) ordered by a clinical provider. Inclusion Criteria (Therapeutic Arm): 1. Participants must have enrolled in the Diagnostic Arm of the study and must have undergone perfusion MR imaging of their painful joint. 2. Participants must have evidence of peri-articular hypervascularity on their perfusion MR exams. This will be determined by the study PIs.
Exclusion criteria
(Diagnostic Arm): 1. Acute injury in the last 12 weeks. 2. Age under 25. 3. Severe degenerative changes of painful joint (shoulder, hip or knee). 4. History of arthroplasty or metallic implant within the painful joint. 5. Severe gadolinium contrast allergy. 6. Severe renal disease or ongoing dialysis. 7. History of malignancy with life expectancy of less than one year, or malignancy with known bone metastasis. 8. Current pregnancy. 9. Formal diagnosis of cognitive impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Clinical Outcome (Hip and Knee, Diagnostic Arm Only) | Score obtained at follow-up visit after 12 months | Composite WOMAC 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) |
| Secondary Clinical Outcome (Shoulder, Diagnostic Arm Only) | Score obtained at follow-up visit after 12 months | Composite WORC survey score |
| 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) |
Countries
United States
Contacts
Primary ContactEric Bultman, MD, PhD
Backup ContactSirish Kishore, MD
Outcome results
None listed