Clinical Trials in the USA / NCT05495334
Recruiting
Observational
Innovations in Genicular Outcomes Registry
NCT05495334 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Knee Osteoarthritis
Investigational drug(s) / intervention(s)
Treatment for Knee OA
Treatment for Knee OA: Pain management treatment for knee OA.
Study summary
The registry will capture prospective data on patients receiving pain management for chronic pain due to knee osteoarthritis (OA) or pain optimization for knee arthroplasty due to knee OA. The OA pain therapies may include cryo nerve block, radiofrequency ablation (RFA), intra-articular (IA) corticosteroids, viscosupplementation, opioids, and others (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\]).
Eligibility
Inclusion Criteria:
1. Planned to receive treatment for knee OA pain including, but not limited to, knee injections, nerve blocking procedures, or knee arthroplasty within 60 days of screening
2. Able to understand the informed consent and assessment questionnaires and have the ability to complete them in the opinion of the investigator
3. Have access to a smartphone or internet access with a computer/tablet to complete the questionnaires using the registry application
Exclusion Criteria:
1. Actively enrolled in an investigational trial that would preclude patients from receiving the site's standard of care for knee OA pain or knee arthroplasty recovery protocol
2. Planning to have a surgery other than on the target knee
Primary outcome measure(s)
- Pain intensity and interference scores via NRS (Numeric Rating Scale) — 18 months
NRS score from 0(being none)-10(being the worst) - Pain intensity and interference scores via BPI-sf (Brief Pain Inventory-short form) — 18 months
Pain intensity and interference scores via BPI-sf 0 to 10, where: 0 = no pain and 10 = pain as bad as you can imagine - Opioid use via pre-and post-treatment analgesic medication use log — 18 months
Opioid use via pre-and post-treatment analgesic medication use log - Functional status via KOOS-JR (Knee injury and Osteoarthritis Outcome Score for Joint Replacement) — 18 months
Functional status via KOOS-JR. 0(none)-4(extreme) - Functional status via SANE (Single Assessment Numeric Evaluation) — 18 months
Functional status via SANE. Percentage of normal (0% to 100% scale with 100% being normal) - Quality of Sleep via PROMIS-SD (PROMIS - Sleep Disturbance - Short Form 8b) — 18 months
Quality of Sleep via PROMIS-SD. 1(Best)-5(Worst) - Adverse events related to pain therapies — 18 months
Adverse events related to pain therapies - General HRQOL via PROMIS-10 (PROMIS GLOBAL-10) — 18 months
General HRQOL via PROMIS-10. 1(Best)-5(Worst) - Patient Satisfaction — 18 months
Patient satisfaction with pain management questionnaire (Patient Satisfaction Questionnaire). Two questions assessing satisfaction and benefit. - Physical therapy utilization and work productivity via PT/Work Productivity — 18 months
Physical therapy (PT) utilization and work productivity via PT/Work Productivity (WP) questionnaire. - Emergency Department (ED) visits — 18 months
Emergency Department (ED) visits - Reimbursement status — 18 months
Reimbursement status - Post-operative pain scores NRS (Numeric Rating Scale) — 18 months
Post-operative pain scores (NRS) 0(being none)-10(being the worst) - Post-operative opioid consumption (analgesic medication use log) — 18 months
Post-operative opioid consumption (analgesic medication use log) - Length of facility stay — 18 months
Length of facility stay
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| The MORE Foundation | Phoenix | Arizona | Recruiting |
| Orthopedic Education and Research Institute of So Ca (Hoag) | Irvine | California | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles | California | Recruiting |
| Florida Orthopaedic Associates | DeLand | Florida | Recruiting |
| MidState Orthopedics and Sports Medicine | Alexandria | Louisiana | Recruiting |
| Louisiana State University /Ochsner | New Orleans | Louisiana | Recruiting |
| Sinai Hospital of Baltimore | Baltimore | Maryland | Recruiting |
| Henry M Jackson Foundation for the Advancement of Military Medicine/Walter Reed National Military Medical Center | Bethesda | Maryland | Terminated |
| Orthopaedic Surgical Associates | North Chelmsford | Massachusetts | Recruiting |
| OrthoNebraska Clinics | Omaha | Nebraska | Recruiting |
| Jersey City Medical Center | Jersey City | New Jersey | Terminated |
| Northwell Health | Garden City | New York | Recruiting |
| Genesee Orthopedics and Plastic Surgery (St. Elizabeth Med Center/ Apex Surgical Center) | New Hartford | New York | Completed |
| Blue Nine Systems | Asheville | North Carolina | Terminated |
| Oklahoma Surgical Hospital | Tulsa | Oklahoma | Recruiting |
| Penn Highlands DuBois | DuBois | Pennsylvania | Recruiting |
| University Orthopedics Center | State College | Pennsylvania | Recruiting |
| Campbell Clinic | Germantown | Tennessee | Recruiting |
| University of Utah | Salt Lake City | Utah | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05495334 on ClinicalTrials.gov ↗ ← All trials in the USA