Recruiting NCT05495334
Innovations in Genicular Outcomes Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Treatment for Knee OA.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 \[NSAIDs\]).
Interventions
- Procedure Treatment for Knee OA
Pain management treatment for knee OA.
Primary outcome measures
- Pain intensity and interference scores via NRS (Numeric Rating Scale) [Time frame: 18 months]
- Pain intensity and interference scores via BPI-sf (Brief Pain Inventory-short form) [Time frame: 18 months]
- Opioid use via pre-and post-treatment analgesic medication use log [Time frame: 18 months]
- Functional status via KOOS-JR (Knee injury and Osteoarthritis Outcome Score for Joint Replacement) [Time frame: 18 months]
- Functional status via SANE (Single Assessment Numeric Evaluation) [Time frame: 18 months]
- Quality of Sleep via PROMIS-SD (PROMIS - Sleep Disturbance - Short Form 8b) [Time frame: 18 months]
- Adverse events related to pain therapies [Time frame: 18 months]
- General HRQOL via PROMIS-10 (PROMIS GLOBAL-10) [Time frame: 18 months]
- Patient Satisfaction [Time frame: 18 months]
- Physical therapy utilization and work productivity via PT/Work Productivity [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 19 centers
- The MORE Foundation — Phoenix
- Orthopedic Education and Research Institute of So Ca (Hoag) — Irvine
- Cedars-Sinai Medical Center — Los Angeles
- Florida Orthopaedic Associates — DeLand
- MidState Orthopedics and Sports Medicine — Alexandria
- Louisiana State University /Ochsner — New Orleans
- Sinai Hospital of Baltimore — Baltimore
- Henry M Jackson Foundation for the Advancement of Military Medicine/Walter Reed National M — Bethesda
- … and 11 more centers
Publications
- 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 39691173
Identifiers
NCT: NCT05495334 · IOV-REG-001