ClinicalTrials.gg
RecruitingNCT05495334iGORUpdated Jul 23, 2026

Innovations in Genicular Outcomes Registry

An observational study in Knee Osteoarthritis, sponsored by Pacira Pharmaceuticals, Inc. Recruiting at 19 sites in United States. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Pacira Pharmaceuticals, Inc · Observational

From the registry’s dates

  • Started Sep 2021; still recruiting 5 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Sex
All
01

Study 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]).

02

Conditions studied

  • Knee Osteoarthritis
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Pacira Pharmaceuticals, Inc is the lead sponsor of 102 studies on the registry; 3 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 17 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

Exclusion Criteria:

  1. Actively enrolled in an 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
18 Months
Patient registry
Yes

Groups and cohorts

  • 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

Interventions

  • ProcedureTreatment for Knee OA

    Pain management treatment for knee OA.

06

What researchers measure

Primary outcomes

  1. Pain intensity and interference scores via NRS (Numeric Rating Scale)

    NRS score from 0(being none)-10(being the worst)

    Time frame: 18 months

  2. 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

    Time frame: 18 months

  3. Opioid use via pre-and post-treatment analgesic medication use log

    Opioid use via pre-and post-treatment analgesic medication use log

    Time frame: 18 months

  4. Functional status via KOOS-JR (Knee injury and Osteoarthritis Outcome Score for Joint Replacement)

    Functional status via KOOS-JR. 0(none)-4(extreme)

    Time frame: 18 months

  5. Functional status via SANE (Single Assessment Numeric Evaluation)

    Functional status via SANE. Percentage of normal (0% to 100% scale with 100% being normal)

    Time frame: 18 months

  6. Quality of Sleep via PROMIS-SD (PROMIS - Sleep Disturbance - Short Form 8b)

    Quality of Sleep via PROMIS-SD. 1(Best)-5(Worst)

    Time frame: 18 months

  7. Adverse events related to pain therapies

    Adverse events related to pain therapies

    Time frame: 18 months

  8. General HRQOL via PROMIS-10 (PROMIS GLOBAL-10)

    General HRQOL via PROMIS-10. 1(Best)-5(Worst)

    Time frame: 18 months

  9. Patient Satisfaction

    Patient satisfaction with pain management questionnaire (Patient Satisfaction Questionnaire). Two questions assessing satisfaction and benefit.

    Time frame: 18 months

  10. Physical therapy utilization and work productivity via PT/Work Productivity

    Physical therapy (PT) utilization and work productivity via PT/Work Productivity (WP) questionnaire.

    Time frame: 18 months

  11. Emergency Department (ED) visits

    Emergency Department (ED) visits

    Time frame: 18 months

  12. Reimbursement status

    Reimbursement status

    Time frame: 18 months

  13. Post-operative pain scores NRS (Numeric Rating Scale)

    Post-operative pain scores (NRS) 0(being none)-10(being the worst)

    Time frame: 18 months

  14. Post-operative opioid consumption (analgesic medication use log)

    Post-operative opioid consumption (analgesic medication use log)

    Time frame: 18 months

  15. Length of facility stay

    Length of facility stay

    Time frame: 18 months

07

Study locations

15 of 19 sites recruiting
  • The MORE Foundation
    Phoenix, Arizona 85023, United States
    Recruiting
    • Anuj Daftari, MD · Principal investigator
  • Orthopedic Education and Research Institute of So Ca (Hoag)
    Irvine, California 92618, United States
    Recruiting
    • Adam Rivadeneyra, MD · Principal investigator
  • Cedars-Sinai Medical Center
    Los Angeles, California 90048, United States
    Recruiting
    • Andrew Spitzer, MD · Principal investigator
  • Florida Orthopaedic Associates
    DeLand, Florida 32720, United States
    Recruiting
    • Mark Hollmann, MD · Principal investigator
  • MidState Orthopedics and Sports Medicine
    Alexandria, Louisiana 71301, United States
    Recruiting
    • David Rogenmoser, DO · Principal investigator
  • Louisiana State University /Ochsner
    New Orleans, Louisiana 70112, United States
    Recruiting
    • Vinod Dasa, MD · Principal investigator
  • Sinai Hospital of Baltimore
    Baltimore, Maryland 21215, United States
    Recruiting
    • Michael Mont, MD · Principal investigator
  • Henry M Jackson Foundation for the Advancement of Military Medicine/Walter Reed National Military Medical Center
    Bethesda, Maryland 20889, United States
    Terminated

    Not enrolling at this site.

  • Orthopaedic Surgical Associates
    North Chelmsford, Massachusetts 01863, United States
    Recruiting
    • Scott Sigman, MD · Principal investigator
  • OrthoNebraska Clinics
    Omaha, Nebraska 68144, United States
    Recruiting
    • Joshua Urban, MD · Principal investigator
  • Jersey City Medical Center
    Jersey City, New Jersey 07302, United States
    Terminated

    Not enrolling at this site.

  • Northwell Health
    Garden City, New York 11530, United States
    Recruiting
    • Giles Scuderi, MD · Principal investigator
  • Genesee Orthopedics and Plastic Surgery (St. Elizabeth Med Center/ Apex Surgical Center)
    New Hartford, New York 13413, United States
    Completed

    Not enrolling at this site.

  • Blue Nine Systems
    Asheville, North Carolina 28801, United States
    Terminated

    Not enrolling at this site.

  • Oklahoma Surgical Hospital
    Tulsa, Oklahoma 74137, United States
    Recruiting
    • Sarat Kunapuli, DO · Principal investigator
  • Penn Highlands DuBois
    DuBois, Pennsylvania 15824, United States
    Recruiting
    • Christopher Varacallo, DO · Principal investigator
  • University Orthopedics Center
    State College, Pennsylvania 16801, United States
    Recruiting
    • Thomas Ellis, DO · Principal investigator
  • Campbell Clinic
    Germantown, Tennessee 38138, United States
    Recruiting
    • William Mihalko, MD · Principal investigator
  • University of Utah
    Salt Lake City, Utah 84108, United States
    Recruiting
    • Alexandra Fogarty, MD · Principal investigator
08

References and documents

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. PubMed 39691173 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05495334
Responsible party
Sponsor
First posted
Aug 10, 2022
Start date
Sep 23, 2021
Primary completion
Jun 30, 2032 (estimated)
Completion
Dec 30, 2033 (estimated)
Last update
Jul 23, 2026

Study contacts

Kate Fasel, BSN
Contact
IGOR@pacira.com
1-520-490-5355

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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