Recruiting NCT07538570
Evaluation of Pain Treatment After Total Knee Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Suzetrigine, Placebo.
- Who it may be relevant to
- Registry conditions: Pain. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 4, Double-blind, Sequential Cohort Study of Pain Treatment and Recovery After Total Knee Arthroplasty
Overview
The purpose of the study is to characterize opioid use after total knee arthroplasty (TKA).
Interventions
- Drug Suzetrigine
Tablets for oral administration. - Drug Placebo
Placebo matched to SUZ for oral administration
Primary outcome measures
- Proportion of Participants who Remain Opioid-Free [Time frame: From Day 1 up to Day 14]
Eligibility criteria
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
Exclusion criteria
\- History of previous TKA surgery on incident side
Other protocol defined Inclusion/Exclusion criteria will apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Legent Orthopedic and Spine Hospital — Bellaire
- Memorial Hermann Village Office — Houston
Identifiers
NCT: NCT07538570 · VX25-548-118