| NCT ID | NCT07864896 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hospital for Special Surgery, New York |
| Condition | Total Knee Arthroplasty (TKA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2026-10-15 |
| Primary Completion | 2029-01 |
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 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 148 participants in total. It began in 2026-10-15 with a primary completion date of 2029-01.
⚠ 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
Total knee replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating suzetrigine in this high-need population may improve recovery trajectories, reduce opioid consumption, and support enhanced recovery protocols. Given the growing surgical volume and the emphasis on opioid-sparing strategies, rigorous investigation of suzetrigine's efficacy in total knee replacement is of high clinical value. In this confirmatory (phase III) trial, patients undergoing primary total knee replacement will be randomized to receive either suzetrigine or placebo for 2 weeks (14 days), with the loading dose administered prior to surgery. The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).
Eligibility Criteria
Inclusion Criteria: * Patients undergoing primary TKA with participating surgeons * Age 18 to 80 years old * Planned Discharge to home * Planned use of neuraxial anesthesia * American Society of Anesthesiologist (ASA) Physical Status 1 - 3 * Patients undergoing primary unilateral TKA with participating surgeons Exclusion Criteria: * ASA greater than 3 * Chronic opioid use (daily MME of greater than 30 mg for at least 3 months and within 1 month of surgery) * History of chronic pain syndromes or uncontrolled pain (i.e. complex regional pain syndrome, fibromyalgia, implanted spinal cord stimulator) * History of QT prolongation * Presence of automated implantable cardioverter defibrillator, pacemaker or cardiac resynchronization device * Evidence of misuse, aberrant use, or addiction to alcohol or an illicitly used drug of abuse, or had a positive test for drugs of abuse * Inability to comply with any component of the study protocol * Younger than 18 or greater than 80 years old at the time of enrollment * Patient already on Suzetrigine * Allergy or contraindication to Suzetrigine or excipients (eg moderate to severe liver disease/Child Pugh B or C, use of strong CYP3 inhibitors or inducers) * Contraindications to neuraxial anesthesia or any other part of the study protocol * Participation in another investigational drug or device study * Pregnancy * Prior osteotomy of the operative knee * Baseline knee flexion \<60° * History of infection or septic arthritis of the operative knee
Contact & Investigator
Meghan Kirskey, MD
PRINCIPAL INVESTIGATOR
Department of Anesthesiology, Critical Care & Pain Management at the Hospital for Special Surgery
Frequently Asked Questions
Who can join the NCT07864896 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Total Knee Arthroplasty (TKA). 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 NCT07864896 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 148 participants.
Is NCT07864896 currently recruiting?
Yes, NCT07864896 is actively recruiting participants. Contact the research team at wehc@hss.edu for enrollment information.
Where is the NCT07864896 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07864896 clinical trial?
NCT07864896 is sponsored by Hospital for Special Surgery, New York. The principal investigator is Meghan Kirskey, MD at Department of Anesthesiology, Critical Care & Pain Management at the Hospital for Special Surgery. The trial plans to enroll 148 participants.