Innovations in Genicular Outcomes Registry (iGOR)

July 21, 2026 updated by: Pacira Pharmaceuticals, Inc
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]).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kate Fasel, BSN
  • Phone Number: 1-520-490-5355
  • Email: IGOR@pacira.com

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Recruiting
        • The MORE Foundation
        • Principal Investigator:
          • Anuj Daftari, MD
    • California
      • Irvine, California, United States, 92618
        • Recruiting
        • Orthopedic Education and Research Institute of So Ca (Hoag)
        • Principal Investigator:
          • Adam Rivadeneyra, MD
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Andrew Spitzer, MD
    • Florida
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Florida Orthopaedic Associates
        • Principal Investigator:
          • Mark Hollmann, MD
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Recruiting
        • MidState Orthopedics and Sports Medicine
        • Principal Investigator:
          • David Rogenmoser, DO
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Louisiana State University /Ochsner
        • Principal Investigator:
          • Vinod Dasa, MD
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Principal Investigator:
          • Michael Mont, MD
      • Bethesda, Maryland, United States, 20889
        • Terminated
        • Henry M Jackson Foundation for the Advancement of Military Medicine/Walter Reed National Military Medical Center
    • Massachusetts
      • North Chelmsford, Massachusetts, United States, 01863
        • Recruiting
        • Orthopaedic Surgical Associates
        • Principal Investigator:
          • Scott Sigman, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • OrthoNebraska Clinics
        • Principal Investigator:
          • Joshua Urban, MD
    • New Jersey
      • Jersey City, New Jersey, United States, 07302
        • Terminated
        • Jersey City Medical Center
    • New York
      • Garden City, New York, United States, 11530
        • Recruiting
        • Northwell Health
        • Principal Investigator:
          • Giles Scuderi, MD
      • New Hartford, New York, United States, 13413
        • Completed
        • Genesee Orthopedics and Plastic Surgery (St. Elizabeth Med Center/ Apex Surgical Center)
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Terminated
        • Blue Nine Systems
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74137
        • Recruiting
        • Oklahoma Surgical Hospital
        • Principal Investigator:
          • Sarat Kunapuli, DO
    • Pennsylvania
      • DuBois, Pennsylvania, United States, 15824
        • Recruiting
        • Penn Highlands DuBois
        • Principal Investigator:
          • Christopher Varacallo, DO
      • State College, Pennsylvania, United States, 16801
        • Recruiting
        • University Orthopedics Center
        • Principal Investigator:
          • Thomas Ellis, DO
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Campbell Clinic
        • Principal Investigator:
          • William Mihalko, MD
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah
        • Principal Investigator:
          • Alexandra Fogarty, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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 informed consent 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:

  1. 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
  2. Planning to have a surgery other than on the target knee

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Pain management treatment for knee OA.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity and interference scores via NRS (Numeric Rating Scale)
Time Frame: 18 months
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)
Time Frame: 18 months
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
Time Frame: 18 months
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)
Time Frame: 18 months
Functional status via KOOS-JR. 0(none)-4(extreme)
18 months
Functional status via SANE (Single Assessment Numeric Evaluation)
Time Frame: 18 months
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)
Time Frame: 18 months
Quality of Sleep via PROMIS-SD. 1(Best)-5(Worst)
18 months
Adverse events related to pain therapies
Time Frame: 18 months
Adverse events related to pain therapies
18 months
General HRQOL via PROMIS-10 (PROMIS GLOBAL-10)
Time Frame: 18 months
General HRQOL via PROMIS-10. 1(Best)-5(Worst)
18 months
Patient Satisfaction
Time Frame: 18 months
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
Time Frame: 18 months
Physical therapy (PT) utilization and work productivity via PT/Work Productivity (WP) questionnaire.
18 months
Emergency Department (ED) visits
Time Frame: 18 months
Emergency Department (ED) visits
18 months
Reimbursement status
Time Frame: 18 months
Reimbursement status
18 months
Post-operative pain scores NRS (Numeric Rating Scale)
Time Frame: 18 months
Post-operative pain scores (NRS) 0(being none)-10(being the worst)
18 months
Post-operative opioid consumption (analgesic medication use log)
Time Frame: 18 months
Post-operative opioid consumption (analgesic medication use log)
18 months
Length of facility stay
Time Frame: 18 months
Length of facility stay
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pacira Pharmaceuticals, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 23, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IOV-REG-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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