Innovations in Genicular Outcomes Registry (IGOR): protocol for a real-world registry study of treatments for knee osteoarthritis.
Vinod Dasa, William Mihalko, Adam Rivadeneyra...
https://pubmed.ncbi.nlm.nih.gov/39691173Actively Recruiting
All Genders
ID05495334
Innovations in Genicular Outcomes Registry for Knee Osteoarthritis Pain Management and Treatment
Led by Pacira Pharmaceuticals, Inc · Updated on 2026-06-08
10000
Participants Needed
19
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients experiencing chronic pain caused by knee osteoarthritis (OA) or those undergoing knee arthroplasty due to knee OA. It aims to collect prospective data on various pain management approaches for these conditions. The study seeks to understand how these therapies affect pain levels, function, quality of life, and treatment outcomes over time. Participants will receive treatments for knee OA pain that may include procedures such as cryo nerve block, radiofrequency ablation (RFA), intra-articular corticosteroids, viscosupplementation, opioids, and other medications like non-steroidal anti-inflammatory drugs (NSAIDs). The study includes patients scheduled for treatment or surgery on the target knee as part of their pain management plan. During the 18-month follow-up, participants will complete questionnaires that assess pain intensity and interference, opioid use, functional status, sleep quality, health-related quality of life, and patient satisfaction. Data on physical therapy use, work productivity, emergency department visits, reimbursement status, postoperative pain and opioid consumption, and length of hospital stay will also be collected. Participants will need access to a smartphone or internet-connected device to complete study questionnaires.
CONDITIONS
Brief Title
Innovations in Genicular Outcomes Registry
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - Up to 60 days
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Varies depending on treatment schedule
Participants receive pain management treatment for knee osteoarthritis, including procedures such as knee injections, nerve blocking, or knee arthroplasty.
1 to 2 visits depending on treatment type
Long-term Monitoring
Duration - Up to 18 months
Participants are monitored for pain intensity, functional status, quality of sleep, medication use, adverse events, and other outcomes related to knee osteoarthritis treatment.
Periodic follow-up visits for up to 18 months
Trial Site Locations
Total: 19 locations
1
The MORE Foundation
Phoenix, Arizona, United States, 85023
Actively Recruiting
2
Orthopedic Education and Research Institute of So Ca (Hoag)
Irvine, California, United States, 92618
Actively Recruiting
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
Florida Orthopaedic Associates
DeLand, Florida, United States, 32720
Actively Recruiting
5
MidState Orthopedics and Sports Medicine
Alexandria, Louisiana, United States, 71301
Actively Recruiting
6
Louisiana State University /Ochsner
New Orleans, Louisiana, United States, 70112
Actively Recruiting
7
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
8
Henry M Jackson Foundation for the Advancement of Military Medicine/Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Terminated
9
Orthopaedic Surgical Associates
North Chelmsford, Massachusetts, United States, 01863
Not Yet Recruiting
10
OrthoNebraska Clinics
Omaha, Nebraska, United States, 68144
Actively Recruiting
11
Jersey City Medical Center
Jersey City, New Jersey, United States, 07302
Terminated
12
Northwell Health
Garden City, New York, United States, 11530
Actively Recruiting
13
Genesee Orthopedics and Plastic Surgery (St. Elizabeth Med Center/ Apex Surgical Center)
New Hartford, New York, United States, 13413
Completed
14
Blue Nine Systems
Asheville, North Carolina, United States, 28801
Terminated
15
Oklahoma Surgical Hospital
Tulsa, Oklahoma, United States, 74137
Actively Recruiting
16
Penn Highlands DuBois
DuBois, Pennsylvania, United States, 15824
Actively Recruiting
17
University Orthopedics Center
State College, Pennsylvania, United States, 16801
Actively Recruiting
18
Campbell Clinic
Germantown, Tennessee, United States, 38138
Actively Recruiting
19
University of Utah
Salt Lake City, Utah, United States, 84108
Not Yet Recruiting
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Research Team
K
Kate Fasel, BSN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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