CompletedNot Applicable

NEUROCUPLE™ in TKA Patients to Enhance Pain Management

United States156 participantsStarted 2024-09-25

Plain-language summary

This is a randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of 30-day application of NEUROCUPLE™ patch for pain reduction and opioid consumption following TKA. Results will establish NEUROCUPLE™ as an effective non-opioid postoperative pain management device for FDA approval. Importantly, we have a placebo device (device without the captor array layer) that looks exactly like the active device, allowing us to conduct a true placebo randomized study.

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 * T-score \< 60 on the PROMIS Anxiety measure 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 * T-score ≥ 60 in any of the three PROMIS measures (i.e., sleep, anxiety, and depression) * 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.

What they're measuring

Post-operative Pain at Rest

Timeframe: 1-Week Post Hospital Discharge

Trial details

NCT IDNCT06460350

SponsornCap Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-18

Results submitted2026-03-04

View on ClinicalTrials.gov More Total Knee Arthroplasty trials