Observational Study, Geniculate Artery, Embolization, Symptomatic Knee Osteoarthritis
Conditions
Brief summary
To explore associations with demographics/clinical factors; assess trajectories via annual follow-up; evaluate healthcare utilization and barriers; oversample \>10-year survivors.
Detailed description
Primary Objective To characterize the change in knee pain and functional disability following standard-of-care GAE in cancer participants with symptomatic knee osteoarthritis, as measured by mean change in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline to 12 months
Interventions
Patients scheduled for standard of care
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥40 years with no upper age restriction, provided performance status permits procedural candidacy 2. Symptomatic mild-to-severe knee osteoarthritis (Kellgren-Lawrence grade 2-4) on radiographs within 6 months of enrollment 3. Chronic knee pain (NRS ≥4/10) for ≥3 months despite conservative treatment including steroid injections, physical therapy, and/or analgesic medications 4. Inadequate candidate for or refusal of surgical intervention (e.g., total knee arthroplasty) due to cancer-related comorbidities, ongoing treatment, or participants preference 5. Active cancer diagnosis (solid tumor or hematologic malignancy) confirmed at MD Anderson Cancer Center
Exclusion criteria
* Active joint infection or suspected septic arthritis * Life expectancy \<6 months * Prior knee arthroplasty in the index knee * Coagulopathy or contraindications to angiography * GFR \<30 mL/min/1.73m² * Peripheral artery disease with stenosis or occlusion of lower extremity vasculature (relative contraindication per SIR standards, given geniculate artery collateral perfusion role) * Radiographically normal knee joint (KL grade 0-1) - alternative etiologies should be sought * Known active autoimmune/inflammatory arthropathy (e.g., rheumatoid arthritis, psoriatic arthritis) * Any medical condition or clinical abnormality that, per investigator judgment, precludes safe participation in and completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale Questionnaire | Through study completion; an average of 1 year |
Countries
United States
Contacts
CONTACTNicolas J Cardenas, MD
PRINCIPAL_INVESTIGATORNicolas J Cardenas, MD
UT MD Anderson Cancer Center
Outcome results
None listed