F14 for Postoperative Pain After Knee Replacement

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Arthritis Innovation Corporation

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests if injecting a long-lasting painkiller called celecoxib into the knee can help reduce pain for patients having knee replacement surgery. The medication works by blocking chemicals that cause pain and swelling. Celecoxib has been shown to be effective in reducing pain and improving function in patients with knee osteoarthritis.

Research Team

Matthew Shive, PhD

Principal Investigator

Arthritis Innovation Corporation

Eligibility Criteria

Adults aged 45-80, with a BMI ≤ 40 kg/m2, scheduled for unilateral total knee replacement surgery can join. They must have stable health as confirmed by tests and no recent injections or major surgeries in the affected knee. Women of childbearing age need a negative pregnancy test and agree to birth control measures.

Inclusion Criteria

Capable of giving signed informed consent and complying with requirements and restrictions listed in the informed consent form (ICF) and in this protocol

My knees do not have severe inward or outward bending.

My health is good enough for surgery according to the ASA score.

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Exclusion Criteria

You have a history of heavy drinking within the past year.

I was diagnosed with bone tissue death in the last year.

You are currently involved in a legal case related to an injury to your knee.

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Treatment Details

Interventions

F14 (Nonsteroidal Anti-inflammatory Drug)

Trial OverviewThe trial is testing F14 (a sustained release form of celecoxib) combined with standard pain management against standard treatment alone after knee replacement surgery. It's randomized and double-blind, meaning neither patients nor doctors know who gets which treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: F14 + Multimodal AnalgesiaExperimental Treatment4 Interventions

Group II: Multimodal AnalgesiaActive Control3 Interventions