Innovations in Genicular Outcomes Registry

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: Treatment for Knee OA

• Registration Number: NCT05495334
• Lead Sponsor: Pacira Pharmaceuticals, Inc

Brief 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 \[NSAIDs\]).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-23
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All participants	Treatment for Knee OA	Eligible and enrolled subjects with knee OA pain who require treatment on the target knee as a part of pain management.

Primary Outcome Measures

Name	Time	Method
Post-operative pain scores NRS (Numeric Rating Scale)	18 months	Post-operative pain scores (NRS) 0(being none)-10(being the worst)
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)
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.
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.
Emergency Department (ED) visits	18 months	Emergency Department (ED) visits
Reimbursement status	18 months	Reimbursement status
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 Locations

Locations (14)

Orthopedic Education and Research Institute of So Ca (Hoag); 🇺🇸 Irvine, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

MidState Orthopedics and Sports Medicine; 🇺🇸 Alexandria, Louisiana, United States

Louisiana State University /Ochsner; 🇺🇸 New Orleans, Louisiana, United States

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Henry M Jackson Foundation for the Advancement of Military Medicine/Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States

OrthoNebraska Clinics; 🇺🇸 Omaha, Nebraska, United States

Jersey City Medical Center; 🇺🇸 Jersey City, New Jersey, United States

Genesee Orthopedics and Plastic Surgery (St. Elizabeth Med Center/ Apex Surgical Center); 🇺🇸 New Hartford, New York, United States

Blue Nine Systems; 🇺🇸 Asheville, North Carolina, United States

Oklahoma Surgical Hospital; 🇺🇸 Tulsa, Oklahoma, United States

Penn Highlands DuBois; 🇺🇸 DuBois, Pennsylvania, United States

University Orthopedics Center; 🇺🇸 State College, Pennsylvania, United States

Campbell Clinic; 🇺🇸 Germantown, Tennessee, United States