Innovations in Genicular Outcomes Registry (iGOR)

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]).

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Treatment for Knee OA

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Medical Information; Phone Number: 1-855-793-9727; Email: MedInfo@pacira.com

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Recruiting
      • Orthopedic Education and Research Institute of So Ca (Hoag)
      • Contact: Adam Rivadeneyra, MD
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Andrew Spitzer, MD
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Recruiting
      • MidState Orthopedics and Sports Medicine
      • Contact: David Rogenmoser, DO
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Louisiana State University /Ochsner
      • Contact: Vinod Dasa, MD
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Recruiting
      • Sinai Hospital of Baltimore
      • Contact: Michael Mont, MD
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Recruiting
      • OrthoNebraska Clinics
      • Contact: Joshua Urban, MD
  • New Jersey
    • Jersey City, New Jersey, United States, 07302
      • Recruiting
      • Jersey City Medical Center
      • Contact: Richard Yoon, MD
  • New York
    • New Hartford, New York, United States, 13413
      • Completed
      • Genesee Orthopedics and Plastic Surgery (St. Elizabeth Med Center/ Apex Surgical Center)
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Recruiting
      • Blue Nine Systems
      • Contact: Lindsey Nelson, MD
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74137
      • Recruiting
      • Oklahoma Surgical Hospital
      • Contact: Sarat Kunapuli, DO
  • Pennsylvania
    • State College, Pennsylvania, United States, 16801
      • Recruiting
      • University Orthopedics Center
      • Contact: Thomas Ellis, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All participants; 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; Pain management treatment for knee OA.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pacira Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: IOV-REG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes