Novel Extended-Release Bupivacaine Polymer for Sustained Pain Relief Following Total Knee Arthroplasty (NCT07775248)
🩺 Plain-English Summary (8th-Grade Level)
Participants are being invited to take part in a research study about pain control after total knee replacement surgery (also called total knee arthroplasty or TKA). The goal of this study is to see if a new long-acting medication, called Zynrelef, can control pain after surgery as well as or better than two other common pain treatments - a nerve block or a standard injection into the knee during surgery. Knee replacement is done to reduce pain and improve movement in people with severe knee arthritis. While the surgery can be very successful, pain during the first few days after surgery can make recovery harder. Many patients need strong opioid pain medicines, but these medicines can have side effects and may lead to dependence. The investigators want to find ways to control pain that reduce or even remove the need for opioids. If participants join this study, they will be randomly placed (like flipping a coin) into one of three groups: Standard injection (PAI) - a mix of medicines injected into the knee during surgery. Zynrelef - a new long-acting medicine put directly into the knee during surgery, along with a smaller dose of the standard injection. Nerve block (ACB) - medicine given near a nerve in the leg before surgery to block pain. All participants will get the same medicines before and after surgery, follow the same physical therapy program, and have the same follow-up visits. Participants will be asked to record their pain scores and the pain medicines they take for several weeks after surgery. The risks of joining are small and similar to those of routine care. All three pain control methods are already used in regular knee replacement surgery. Possible side effects may include temporary numbness, weakness, or soreness from the injections, and the usual surgical risks such as infection. Participants may benefit from better pain control, less need for opioids, and a smoother recovery. The results from this study may also help future patients have safer and more comfortable knee replacements. Taking part is voluntary. Participants can leave the study at any time without affecting their medical care.
Who can join: Review the eligibility criteria below.
Location: Henry Ford Medical Center - Grosse Pointe Cottage — Grosse Pointe Farms, Michigan
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Henry Ford Medical Center - Grosse Pointe Cottage — Grosse Pointe Farms, Michigan
📞 Contact the Study Coordinator
Phone: (313) 916-9388
Email: tnorth1@hfhs.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Osteoarthritis (OA) of the Knee
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- INJECTABLE COLD ENERGY THERAPY FOR THE MANAGEMENT OF CHRONIC PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE — Larkspur, California
- Pain Perception During Intra-Articular Knee Joint Injection: What is the Effect of Needle Gauge and the Use of Ethyl Chloride? — Sacramento, California
- The GORUN Study: Gradual Onset of RUNning and Knee Joint Health in Novice Runners — Vancouver, British Columbia
- Pharmacist-physiotherapist Collaborative Management for Early Knee Osteoarthritis — Sherwood Park, Alberta
Explore by condition: All Osteoarthritis (OA) of the Knee clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.