NCT07775248 Novel Extended-Release Bupivacaine Polymer for Sustained Pain Relief Following Total Knee Arthroplasty
| NCT ID | NCT07775248 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Henry Ford Health System |
| Condition | Osteoarthritis (OA) of the Knee |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2026-10-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2025-02-11 with a primary completion date of 2026-10-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Adult patients age 18 and older undergoing primary total knee replacement by fellowship trained Orthopedic Surgeons in Henry Ford Health System with planned outpatient same-day discharge. Exclusion Criteria: * Incomplete data in medical records * Non-English speakers * Chronic opioid use in the last 3 months * Ipsilateral joint surgery in the last year * Undergoing bilateral knee arthroplasty * Cannot tolerate oral medications * Swallowing difficulties * Intolerance to acetaminophen, anti-inflammatories, muscle relaxants, gabapentinoids, or opioids/tramadol * History of alcohol abuse * Drug abuse * Renal impairment * Peptic ulcer disease * GI bleeding * Illicit narcotic usage in the past 6 months * Chronic liver disease * Chronic pain syndromes
Frequently Asked Questions
Who can join the NCT07775248 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Osteoarthritis (OA) of the Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07775248 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07775248 currently recruiting?
Yes, NCT07775248 is actively recruiting participants. Visit ClinicalTrials.gov or contact Henry Ford Health System to inquire about joining.
Where is the NCT07775248 trial being conducted?
This trial is being conducted at Grosse Pointe Farms, United States.
Who is sponsoring the NCT07775248 clinical trial?
NCT07775248 is sponsored by Henry Ford Health System. The trial plans to enroll 150 participants.