Innovations in Genicular Outcomes Registry

Study Overview
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Brief Summary
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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]).

Official Title
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Innovations in Genicular Outcomes Registry

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Treatment for Knee OA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Able to understand the informed consent and assessment questionnaires and have the ability to complete them in the opinion of the investigator Have access to a smartphone or internet access with a computer/tablet to complete the questionnaires using the registry application Exclusion Criteria: 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 Planning to have a surgery other than on the target knee
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All participants<br>Eligible and enrolled subjects with knee OA pain who require treatment on the target knee as a part of pain management. | Procedure: Treatment for Knee OA<br>* Pain management treatment for knee OA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 |