Health TrialsbyHealthPanel

Innovations in Genicular Outcomes Registry

ConditionKnee Osteoarthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPacira Pharmaceuticals, Inc

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Treatment for Knee OA

    Procedure/Surgery

    Pain management treatment for knee OA.

Treatment groups

10,000 Participants
are divided into 1 treatment group
Group A: All participants1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
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

Time frame
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

Time frame
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)

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pacira Pharmaceuticals, Inc

Lead sponsor

Source ClinicalTrials.gov
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