Exparel and Zynrelef for Total Knee Replacement Recovery

DW
AN
Overseen ByAndy Nguyen, BS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Foundation for Orthopaedic Research and Education
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study looks at how three different numbing injections affect how quickly patients recover after knee replacement surgery (total knee arthroplasty, or TKA). Pain after knee replacement is common and can slow down how soon patients get moving again. Doctors often inject a numbing medication around the knee during surgery to help control this pain, but it is not clear which medication helps patients recover fastest in the first few days after surgery.

The study compares three injections that are all FDA approved and already used as part of routine knee replacement care: Exparel (liposomal bupivacaine), Zynrelef (bupivacaine with meloxicam), and Marcaine (bupivacaine). Exparel and Zynrelef are the two groups being studied, and Marcaine is the comparison (control) group.

Adults who are already planning to have a knee replacement may take part. People who join are placed into one of the three injection groups at random, so each person has a one in three chance of receiving each injection. Patients are not told which injection they received. Everything else about the surgery, anesthesia, and recovery care stays the same as usual.

The main goal is to see which injection helps patients recover best in the first three days after surgery. To measure recovery, the study team collects information on pain, pain-medication use, knee motion, activity level, and function. Patients complete short questionnaires about their activity, pain, and quality of life at their regular visits (before surgery and at 3 days, 1 week, 2 weeks, 6 weeks, 3 months, 1 year, and 2 years). A smart knee implant also records information about knee movement and motion at 3 and 7 days after surgery. About 200 people will take part. The study is considered minimal risk, meaning the risks are similar to those of having a knee replacement outside of the study.

Who Is on the Research Team?

SL

Steven Lyons, MD

Principal Investigator

Florida Orthopaedic Institute

Are You a Good Fit for This Trial?

This trial is for adults scheduled to have a total knee replacement. Participants must be able to complete study visits and questionnaires. People with certain medical conditions or allergies may not be eligible.

Inclusion Criteria

Willing and able to provide written informed consent and to complete the first-week assessment schedule
I am scheduled to get a specific pain injection during my surgery.
I can complete the Timed Up and Go test in under 20 seconds.
See 1 more

Exclusion Criteria

Morbid obesity with BMI greater than 40 kg/m2
Chronic opioid use
Documented allergy or intolerance to amide-type local anesthetics
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Bupivacaine
  • Exparel
  • Zynrelef

Trial Overview

The study compares three types of numbing injections—Exparel, Zynrelef, and Marcaine—given during knee replacement surgery. Patients are randomly assigned to one group, and recovery is tracked using smart implants and surveys over two years.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: ZynrelefExperimental Treatment1 Intervention
Group II: ExparelExperimental Treatment1 Intervention
Group III: BupivicaineActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Foundation for Orthopaedic Research and Education

Lead Sponsor

Trials
16
Recruited
1,000+

Zimmer Biomet

Industry Sponsor

Trials
383
Recruited
67,800+
Dr. Nitin Goyal profile image

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos profile image

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Florida Orthopaedic Institute

Collaborator

Trials
9
Recruited
480+