Recruiting

Observational StudyInnovations in Genicular Outcomes Registry

Sponsor:

Pacira Pharmaceuticals, Inc

Code:

NCT05495334

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Treatment for Knee OA

Study Details

Brief 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 \[NSAIDs\]).

Conditions

Knee Osteoarthritis

Study ID

NCT05495334

Start date

Sep 23, 2021

Status verified date

Jul, 2026

Completion date

Dec 30, 2033

Anticipated

Primary completion date

Jun 30, 2032

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

All participants

Eligible and enrolled subjects with knee OA pain who require treatment on the target knee as a part of pain management.

Interventions

Treatment for Knee OA

Pain management treatment for knee OA.

Primary outcome measure

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 ]
Emergency Department (ED) visits [ Time Frame: 18 months ]
Reimbursement status [ Time Frame: 18 months ]
Post-operative pain scores NRS (Numeric Rating Scale) [ Time Frame: 18 months ]
Post-operative opioid consumption (analgesic medication use log) [ Time Frame: 18 months ]
Length of facility stay [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Kate Fasel, BSN

1-520-490-5355 IGOR@pacira.com

Locations

The MORE Foundation

Recruiting

Phoenix, Arizona, United States, 85023

Principal Investigator:

Anuj Daftari, MD

Orthopedic Education and Research Institute of So Ca (Hoag)

Recruiting

Irvine, California, United States, 92618

Principal Investigator:

Adam Rivadeneyra, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Andrew Spitzer, MD

Florida Orthopaedic Associates

Recruiting

DeLand, Florida, United States, 32720

Principal Investigator:

Mark Hollmann, MD

MidState Orthopedics and Sports Medicine

Recruiting

Alexandria, Louisiana, United States, 71301

Principal Investigator:

David Rogenmoser, DO

Louisiana State University /Ochsner

Recruiting

New Orleans, Louisiana, United States, 70112

Principal Investigator:

Vinod Dasa, MD

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Principal Investigator:

Michael Mont, MD

Orthopaedic Surgical Associates

Recruiting

North Chelmsford, Massachusetts, United States, 01863

Principal Investigator:

Scott Sigman, MD

OrthoNebraska Clinics

Recruiting

Omaha, Nebraska, United States, 68144

Principal Investigator:

Joshua Urban, MD

Northwell Health

Recruiting

Garden City, New York, United States, 11530

Principal Investigator:

Giles Scuderi, MD

Oklahoma Surgical Hospital

Recruiting

Tulsa, Oklahoma, United States, 74137

Principal Investigator:

Sarat Kunapuli, DO

Penn Highlands DuBois

Recruiting

DuBois, Pennsylvania, United States, 15824

Principal Investigator:

Christopher Varacallo, DO

University Orthopedics Center

Recruiting

State College, Pennsylvania, United States, 16801

Principal Investigator:

Thomas Ellis, DO

Campbell Clinic

Recruiting

Germantown, Tennessee, United States, 38138

Principal Investigator:

William Mihalko, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Principal Investigator:

Alexandra Fogarty, MD

More Information

Sponsor

Pacira Pharmaceuticals, Inc

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pacira Pharmaceuticals, Inc on 2026-07-23.