NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty (NCT07439666) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty
United States274 participantsStarted 2026-05
Plain-language summary
The goal of this clinical trial is to learn if the NEUROCUPLE device can reduce pain and opioid use after primary unilateral total knee arthroplasty (TKA) in adults.
The main questions it aims to answer are:
* Does the NEUROCUPLE device reduce postoperative pain at rest during the first 24 hours after TKA?
* Does the NEUROCUPLE device reduce opioid consumption during the first 24 hours after TKA?
Researchers will compare the NEUROCUPLE device to a placebo device (identical in appearance but inactive) to see if the device reduces pain and opioid use after surgery.
Participants will:
* Apply the NEUROCUPLE device or placebo device for 7 days following surgery
* Have their pain and opioid use monitored through clinical records and patient reporting
* Report pain at rest and during movement on postoperative Days 2 and 7
* Be assessed for nausea, vomiting, device-related side effects, length of hospital stay, and overall satisfaction
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \>18 years of age
* Scheduled for elective primary unilateral TKA
Exclusion Criteria:
* Children (\<18 yr.)
* Pregnant women
* Active alcoholism (defined as daily use of more than 1 liter of wine and /or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs)
* Severe chronic pain condition that requires daily preoperative opioid dependence
* Other concomitant surgery being performed in addition to TKA
* Patients undergoing bilateral TKA
* Patients undergoing knee replacement revision
* Patients with limited mobility (in a wheelchair or requiring a walker)
* Patients who are not returning home after surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.