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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]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Eligible and enrolled subjects with knee OA pain who require treatment on the target knee as a part of pain management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment for Knee OA | Procedure | Pain management treatment for knee OA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity and interference scores via NRS (Numeric Rating Scale) | NRS score from 0(being none)-10(being the worst) | 18 months |
| Pain intensity and interference scores via BPI-sf (Brief Pain Inventory-short form) | Pain intensity and interference scores via BPI-sf 0 to 10, where: 0 = no pain and 10 = pain as bad as you can imagine | 18 months |
| Opioid use via pre-and post-treatment analgesic medication use log | Opioid use via pre-and post-treatment analgesic medication use log | 18 months |
| Functional status via KOOS-JR (Knee injury and Osteoarthritis Outcome Score for Joint Replacement) | Functional status via KOOS-JR. 0(none)-4(extreme) | 18 months |
| Functional status via SANE (Single Assessment Numeric Evaluation) | Functional status via SANE. Percentage of normal (0% to 100% scale with 100% being normal) | 18 months |
| Quality of Sleep via PROMIS-SD (PROMIS - Sleep Disturbance - Short Form 8b) | Quality of Sleep via PROMIS-SD. 1(Best)-5(Worst) | 18 months |
| Adverse events related to pain therapies | Adverse events related to pain therapies | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who are planned to receive treatment within 60 days of screening for knee OA pain will be screened, and if eligible, will be approached for participation in the registry.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kate Fasel, BSN | Contact | 1-520-490-5355 | IGOR@pacira.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The MORE Foundation | Recruiting | Phoenix | Arizona | 85023 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39691173 | Derived | Dasa V, Mihalko W, Rivadeneyra A, Urban J, Wickline A, Rogenmoser D, Concoff A, Spitzer A, Mont MA. Innovations in Genicular Outcomes Registry (IGOR): protocol for a real-world registry study of treatments for knee osteoarthritis. Ther Adv Musculoskelet Dis. 2024 Dec 16;16:1759720X241304193. doi: 10.1177/1759720X241304193. eCollection 2024. |
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| General HRQOL via PROMIS-10 (PROMIS GLOBAL-10) |
General HRQOL via PROMIS-10. 1(Best)-5(Worst) |
| 18 months |
| Patient Satisfaction | Patient satisfaction with pain management questionnaire (Patient Satisfaction Questionnaire). Two questions assessing satisfaction and benefit. | 18 months |
| Physical therapy utilization and work productivity via PT/Work Productivity | Physical therapy (PT) utilization and work productivity via PT/Work Productivity (WP) questionnaire. | 18 months |
| Emergency Department (ED) visits | Emergency Department (ED) visits | 18 months |
| Reimbursement status | Reimbursement status | 18 months |
| Post-operative pain scores NRS (Numeric Rating Scale) | Post-operative pain scores (NRS) 0(being none)-10(being the worst) | 18 months |
| Post-operative opioid consumption (analgesic medication use log) | Post-operative opioid consumption (analgesic medication use log) | 18 months |
| Length of facility stay | Length of facility stay | 18 months |
| Orthopedic Education and Research Institute of So Ca (Hoag) | Recruiting | Irvine | California | 92618 | United States |
|
| Cedars-Sinai Medical Center | Recruiting | Los Angeles | California | 90048 | United States |
|
| Florida Orthopaedic Associates | Recruiting | DeLand | Florida | 32720 | United States |
|
| MidState Orthopedics and Sports Medicine | Recruiting | Alexandria | Louisiana | 71301 | United States |
|
| Louisiana State University /Ochsner | Recruiting | New Orleans | Louisiana | 70112 | United States |
|
| Sinai Hospital of Baltimore | Recruiting | Baltimore | Maryland | 21215 | United States |
|
| Henry M Jackson Foundation for the Advancement of Military Medicine/Walter Reed National Military Medical Center | Terminated | Bethesda | Maryland | 20889 | United States |
| Orthopaedic Surgical Associates | Recruiting | North Chelmsford | Massachusetts | 01863 | United States |
|
| OrthoNebraska Clinics | Recruiting | Omaha | Nebraska | 68144 | United States |
|
| Jersey City Medical Center | Terminated | Jersey City | New Jersey | 07302 | United States |
| Northwell Health | Recruiting | Garden City | New York | 11530 | United States |
|
| Genesee Orthopedics and Plastic Surgery (St. Elizabeth Med Center/ Apex Surgical Center) | Completed | New Hartford | New York | 13413 | United States |
| Blue Nine Systems | Terminated | Asheville | North Carolina | 28801 | United States |
| Oklahoma Surgical Hospital | Recruiting | Tulsa | Oklahoma | 74137 | United States |
|
| Penn Highlands DuBois | Recruiting | DuBois | Pennsylvania | 15824 | United States |
|
| University Orthopedics Center | Recruiting | State College | Pennsylvania | 16801 | United States |
|
| Campbell Clinic | Recruiting | Germantown | Tennessee | 38138 | United States |
|
| University of Utah | Not yet recruiting | Salt Lake City | Utah | 84108 | United States |
|
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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