AzTrials
AzTrials

Knee OsteoarthritisiGORNCT05495334

Innovations in Genicular Outcomes Registry

An observational study of Knee Osteoarthritis, run by Pacira Pharmaceuticals, Inc at 19 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Treatment for Knee OA
Type of treatment
Surgery or procedure
How many people
10,000 participants
Where
19 sitesUnited States
Study dates
23 Sep 2021to 30 Dec 2033
How long will I take part?
18 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kate Fasel, BSN contact

1-520-490-5355

IGOR@pacira.com

19 sites in 1 country

United States19 sites, 15 recruiting

  • MidState Orthopedics and Sports Medicine

    Alexandria, Louisiana, 71301

    David Rogenmoser, DO

    Recruiting

  • Blue Nine Systems

    Asheville, North Carolina, 28801

    Terminated

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

    Michael Mont, MD

    Recruiting

  • Henry M Jackson Foundation for the Advancement of Military Medicine/Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

    Terminated

  • Florida Orthopaedic Associates

    DeLand, Florida, 32720

    Mark Hollmann, MD

    Recruiting

  • Penn Highlands DuBois

    DuBois, Pennsylvania, 15824

    Christopher Varacallo, DO

    Recruiting

  • Northwell Health

    Garden City, New York, 11530

    Giles Scuderi, MD

    Recruiting

  • Campbell Clinic

    Germantown, Tennessee, 38138

    William Mihalko, MD

    Recruiting

  • Orthopedic Education and Research Institute of So Ca (Hoag)

    Irvine, California, 92618

    Adam Rivadeneyra, MD

    Recruiting

  • Jersey City Medical Center

    Jersey City, New Jersey, 07302

    Terminated

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Andrew Spitzer, MD

    Recruiting

  • Genesee Orthopedics and Plastic Surgery (St. Elizabeth Med Center/ Apex Surgical Center)

    New Hartford, New York, 13413

    Completed

  • Louisiana State University /Ochsner

    New Orleans, Louisiana, 70112

    Vinod Dasa, MD

    Recruiting

  • Orthopaedic Surgical Associates

    North Chelmsford, Massachusetts, 01863

    Scott Sigman, MD

    Recruiting

  • OrthoNebraska Clinics

    Omaha, Nebraska, 68144

    Joshua Urban, MD

    Recruiting

  • The MORE Foundation

    Phoenix, Arizona, 85023

    Anuj Daftari, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84108

    Alexandra Fogarty, MD

    Recruiting

  • University Orthopedics Center

    State College, Pennsylvania, 16801

    Thomas Ellis, DO

    Recruiting

  • Oklahoma Surgical Hospital

    Tulsa, Oklahoma, 74137

    Sarat Kunapuli, DO

    Recruiting

Other trials in United States

About this study

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]).

Being tested
Treatment for Knee OA
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment for Knee OAProcedure or surgery

    Pain management treatment for knee OA.

Study groups in NCT05495334
Study groupRoleWhat they receive
All participantsEligible and enrolled subjects with knee OA pain who require treatment on the target knee as a part of pain management.
Receives: Procedure: Treatment for Knee OA

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 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)

    Measured: 18 months

  7. Adverse events related to pain therapies

    Adverse events related to pain therapies

    Measured: 18 months

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

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

    Measured: 18 months

  9. Patient Satisfaction

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

    Measured: 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.

    Measured: 18 months

  11. Emergency Department (ED) visits

    Emergency Department (ED) visits

    Measured: 18 months

  12. Reimbursement status

    Reimbursement status

    Measured: 18 months

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

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

    Measured: 18 months

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

    Post-operative opioid consumption (analgesic medication use log)

    Measured: 18 months

  15. Length of facility stay

    Length of facility stay

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2022
  2. Study start23 Sep 2021
  3. Primary completion30 Jun 2032 (estimated)
  4. Study completion30 Dec 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
Target duration
18 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05495334
Sponsor's protocol ID
IOV-REG-001
Acronym
iGOR
Status last verified
Jul 2026
First submitted
14 Jul 2022
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Knee Osteoarthritis, run by Pacira Pharmaceuticals, Inc at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kate Fasel, BSN (1-520-490-5355, IGOR@pacira.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity and interference scores via NRS (Numeric Rating Scale) (time frame: 18 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05495334, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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