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Recruiting

NCT Number: NCT05495334

Innovations in Genicular Outcomes Registry

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]).

Recruiting

Interested in participating?

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

The MORE Foundation, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment for Knee OA

Procedure

Pain management treatment for knee OA.

Primary outcomes

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

    Time frame: 18 months

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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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)

  7. Adverse events related to pain therapies

    Time frame: 18 months

    Adverse events related to pain therapies

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

    Time frame: 18 months

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

  9. Patient Satisfaction

    Time frame: 18 months

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

  10. 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.

  11. Emergency Department (ED) visits

    Time frame: 18 months

    Emergency Department (ED) visits

  12. Reimbursement status

    Time frame: 18 months

    Reimbursement status

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

    Time frame: 18 months

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

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

    Time frame: 18 months

    Post-operative opioid consumption (analgesic medication use log)

  15. Length of facility stay

    Time frame: 18 months

    Length of facility stay

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Fasel, BSN

CONTACT

[email protected]

1-520-490-5355

Sponsors and collaborators

Lead sponsor

Pacira Pharmaceuticals, Inc

Industry

Registry information

Acronym: iGOR

Important dates

Study start
2021
Primary completion
2032
Study completion
2033
First posted
Aug 10, 2022
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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