Exparel and Zynrelef for Total Knee Replacement Recovery
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?
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
Exclusion Criteria
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
These patients will receive Zynrelef as their Intra-articular injection
These patients will receive Exparel as their Intra-articular injection
These patients will receive Bupivicaine as their Intra-articular injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Foundation for Orthopaedic Research and Education
Lead Sponsor
Zimmer Biomet
Industry Sponsor
Dr. Nitin Goyal
Zimmer Biomet
Chief Medical Officer since 2021
MD from Harvard Medical School
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
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.