An observational study in Osteoarthritis, Knee, Osteoarthritis, Hip and Osteo Arthritis Shoulders, sponsored by Palo Alto Veterans Institute for Research. Recruiting at 1 site in United States. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Palo Alto Veterans Institute for Research · Observational
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Palo Alto Veterans Institute for Research is the lead sponsor of 53 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria (Both Arms):
Inclusion Criteria (Therapeutic Arm):
Exclusion Criteria (Diagnostic Arm):
Exclusion Criteria (Therapeutic Arm):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Fluoroscopically-guided arterial embolization of synovitis in the painful shoulder, hip or knee.
Primary Clinical Outcome (Hip and Knee, Therapeutic Arm Only)
Composite WOMAC survey score
Time frame: Score obtained at follow-up visit 6 months after intervention
Primary Clinical Outcome (Shoulder, Therapeutic Arm Only)
Composite WORC survey score
Time frame: 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)
Time frame: Research MRI obtained 3 months after intervention
Secondary Clinical Outcome (Hip and Knee, Diagnostic Arm Only)
Composite WOMAC survey score
Time frame: Score obtained at follow-up visit after 12 months
Secondary Clinical Outcome (Shoulder, Diagnostic Arm Only)
Composite WORC survey score
Time frame: 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)
Time frame: 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)
Time frame: Research MRI obtained after 12 months of follow-up
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Mar 2026, 31 months after the start.
Of 179 non-industry observational studies under Osteoarthritis, Knee, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 31 months is above that.
Counting every sponsor, half of 220 studies reached it within 24 months; a quarter within 14 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
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Palo Alto Veterans Institute for Research