Innovations in Genicular Outcomes Registry
iGOR
1 other identifier
observational
10,000
1 country
17
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 \[NSAIDs\]).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2021
CompletedFirst Submitted
Initial submission to the registry
July 14, 2022
CompletedFirst Posted
Study publicly available on registry
August 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2033
February 11, 2026
February 1, 2026
10.8 years
July 14, 2022
February 10, 2026
Conditions
Outcome Measures
Primary Outcomes (15)
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
Study Arms (1)
All participants
Eligible and enrolled subjects with knee OA pain who require treatment on the target knee as a part of pain management.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
The MORE Foundation
Phoenix, Arizona, 85023, United States
Orthopedic Education and Research Institute of So Ca (Hoag)
Irvine, California, 92618, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
MidState Orthopedics and Sports Medicine
Alexandria, Louisiana, 71301, United States
Louisiana State University /Ochsner
New Orleans, Louisiana, 70112, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Henry M Jackson Foundation for the Advancement of Military Medicine/Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
OrthoNebraska Clinics
Omaha, Nebraska, 68144, United States
Jersey City Medical Center
Jersey City, New Jersey, 07302, United States
Northwell Health
Garden City, New York, 11530, United States
Genesee Orthopedics and Plastic Surgery (St. Elizabeth Med Center/ Apex Surgical Center)
New Hartford, New York, 13413, United States
Blue Nine Systems
Asheville, North Carolina, 28801, United States
Oklahoma Surgical Hospital
Tulsa, Oklahoma, 74137, United States
Penn Highlands DuBois
DuBois, Pennsylvania, 15824, United States
University Orthopedics Center
State College, Pennsylvania, 16801, United States
Campbell Clinic
Germantown, Tennessee, 38138, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Related Publications (1)
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.
PMID: 39691173DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2022
First Posted
August 10, 2022
Study Start
September 23, 2021
Primary Completion (Estimated)
June 30, 2032
Study Completion (Estimated)
December 30, 2033
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share