At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Enhancing Pain Management for Knee Replacement Patients Through an Innovative Non-invasive and Opioid-sparing Device (NEUROCUPLE™)
In Brief
A clinical study evaluating NEUROCUPLE™ Patch and Placebo Patch for Total Knee Arthroplasty. Completed, enrolled 156 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.
Interventions
nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year.
The placebo patch is identical to the active patch but with no active agents.