Clinical trial NCT05495334: Innovations in Genicular Outcomes Registry
Official title: Innovations in Genicular Outcomes Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2022-08-10
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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 \[NSAIDs\]).


Eligibility criteria: 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

Primary outcomes:
measure: Pain intensity and interference scores via NRS (Numeric Rating Scale)
timeFrame: 18 months
measure: Pain intensity and interference scores via BPI-sf (Brief Pain Inventory-short form)
timeFrame: 18 months
measure: Opioid use via pre-and post-treatment analgesic medication use log
timeFrame: 18 months
measure: Functional status via KOOS-JR (Knee injury and Osteoarthritis Outcome Score for Joint Replacement)
timeFrame: 18 months
measure: Functional status via SANE (Single Assessment Numeric Evaluation)
timeFrame: 18 months
measure: Quality of Sleep via PROMIS-SD (PROMIS - Sleep Disturbance - Short Form 8b)
timeFrame: 18 months
measure: Adverse events related to pain therapies
timeFrame: 18 months
measure: General HRQOL via PROMIS-10 (PROMIS GLOBAL-10)
timeFrame: 18 months
measure: Patient Satisfaction
timeFrame: 18 months
measure: Physical therapy utilization and work productivity via PT/Work Productivity
timeFrame: 18 months
measure: Emergency Department (ED) visits
timeFrame: 18 months
measure: Reimbursement status
timeFrame: 18 months
measure: Post-operative pain scores NRS (Numeric Rating Scale)
timeFrame: 18 months
measure: Post-operative opioid consumption (analgesic medication use log)
timeFrame: 18 months
measure: Length of facility stay
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Orthopedic Education and Research Institute of So Ca (Hoag)
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Alexandria
country: United States
facility: MidState Orthopedics and Sports Medicine
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana State University /Ochsner
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Bethesda
country: United States
facility: Henry M Jackson Foundation for the Advancement of Military Medicine/Walter Reed National Military Medical Center
state: Maryland
city: Omaha
country: United States
facility: OrthoNebraska Clinics
state: Nebraska
city: Jersey City
country: United States
facility: Jersey City Medical Center
state: New Jersey
city: New Hartford
country: United States
facility: Genesee Orthopedics and Plastic Surgery (St. Elizabeth Med Center/ Apex Surgical Center)
state: New York
city: Asheville
country: United States
facility: Blue Nine Systems
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma Surgical Hospital
state: Oklahoma
city: DuBois
country: United States
facility: Penn Highlands DuBois
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
Study officials:
References: