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 range18 Years

SexALL

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

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

View on ClinicalTrials.gov More Total Knee Arthroplasty trials