Pain treatment after total knee replacement
A Phase 4, Double-blind, Sequential Cohort Study of Pain Treatment and Recovery After Total Knee Arthroplasty
This study will test whether suzetrigine, compared with placebo, reduces opioid use after elective primary total knee replacement in adults.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Vertex Pharmaceuticals Incorporated Industry-sponsored |
| Locations | 2 sites (Bellaire, Texas and 1 other locations) |
| Trial ID | NCT07538570 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional trial enrolls adults scheduled for elective primary unilateral total knee arthroplasty who meet BMI and other protocol criteria and have not had previous TKA on the same side. Participants will receive either suzetrigine or placebo around the time of surgery and postoperative opioid use will be characterized. Key eligibility includes a BMI of 18.0–40.0 kg/m2 and no prior TKA on the incident side. The trial is sponsored by Vertex Pharmaceuticals and conducted at sites in the Houston, Texas area.
Who should consider this trial
Good fit: Adults with a BMI between 18.0 and 40.0 kg/m2 who are scheduled for an elective primary unilateral total knee arthroplasty and have not had prior knee replacement on the same side.
Not a fit: Patients who have had a previous TKA on the same knee, who fall outside the BMI range, or who are not having an elective primary unilateral TKA are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, this could reduce how much opioid medication patients need after knee replacement and lower opioid-related side effects.
How similar studies have performed: Some other non-opioid perioperative approaches have reduced postoperative opioid use in past studies, but suzetrigine's specific effect after TKA is not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Body mass index (BMI) of greater than or equal to (≥) 18.0 to less than or equal to (≤) 40.0 kilogram per meter square (kg/m\^2) * Scheduled to undergo an elective primary unilateral TKA surgery Key Exclusion Criteria: \- History of previous TKA surgery on incident side Other protocol defined Inclusion/Exclusion criteria will apply.
Where this trial is running
Bellaire, Texas and 1 other locations
- Legent Orthopedic and Spine Hospital — Bellaire, Texas, United States (Recruiting)
- Memorial Hermann Village Office — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Medical Information
- Email: medicalinfo@vrtx.com
- Phone: 617-341-6777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.