Innovations in Genicular Outcomes Registry

Knee Osteoarthritis Clinical Trial

— iGOR  

Official title:

Innovations in Genicular Outcomes Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05495334
• Other study ID #: IOV-REG-001
• Status: Recruiting
• Start date: September 23, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: Pacira Pharmaceuticals, Inc
• Contact: Medical Information
• Phone: 1-855-793-9727
• Email: MedInfo[@]pacira.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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]).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Treatment for Knee OA
Pain management treatment for knee OA.

Locations

Country	Name	City	State
United States	MidState Orthopedics and Sports Medicine	Alexandria	Louisiana
United States	Blue Nine Systems	Asheville	North Carolina
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Penn Highlands DuBois	DuBois	Pennsylvania
United States	Orthopedic Education and Research Institute of So Ca (Hoag)	Irvine	California
United States	Jersey City Medical Center	Jersey City	New Jersey
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Genesee Orthopedics and Plastic Surgery (St. Elizabeth Med Center/ Apex Surgical Center)	New Hartford	New York
United States	Louisiana State University /Ochsner	New Orleans	Louisiana
United States	OrthoNebraska Clinics	Omaha	Nebraska
United States	University Orthopedics Center	State College	Pennsylvania
United States	Oklahoma Surgical Hospital	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity and interference scores via NRS (Numeric Rating Scale)	NRS score from 0(being none)-10(being the worst)	18 months
Primary	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
Primary	Opioid use via pre-and post-treatment analgesic medication use log	Opioid use via pre-and post-treatment analgesic medication use log	18 months
Primary	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
Primary	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
Primary	Quality of Sleep via PROMIS-SD (PROMIS - Sleep Disturbance - Short Form 8b)	Quality of Sleep via PROMIS-SD. 1(Best)-5(Worst)	18 months
Primary	Adverse events related to pain therapies	Adverse events related to pain therapies	18 months
Primary	General HRQOL via PROMIS-10 (PROMIS GLOBAL-10)	General HRQOL via PROMIS-10. 1(Best)-5(Worst)	18 months
Primary	Patient Satisfaction	Patient satisfaction with pain management questionnaire (Patient Satisfaction Questionnaire). Two questions assessing satisfaction and benefit.	18 months
Primary	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
Primary	Emergency Department (ED) visits	Emergency Department (ED) visits	18 months
Primary	Reimbursement status	Reimbursement status	18 months
Primary	Post-operative pain scores NRS (Numeric Rating Scale)	Post-operative pain scores (NRS) 0(being none)-10(being the worst)	18 months
Primary	Post-operative opioid consumption (analgesic medication use log)	Post-operative opioid consumption (analgesic medication use log)	18 months
Primary	Length of facility stay	Length of facility stay	18 months