NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty
What You Need to Know Before You Apply
What is the purpose of this trial?
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 Is on the Research Team?
Jacques E. Chelly, MD, PhD, MBA
Principal Investigator
University of Pittsburgh / UPMC
Amy Monroe, MPH, MBA
Principal Investigator
University of Pittsburgh / UPMC
Are You a Good Fit for This Trial?
Inclusion Criteria
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 7 days following their TKA surgery.
This arm of subjects will receive the placebo (non-active, sham) patch to wear for 7 days following their TKA surgery.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jacques E. Chelly
Lead Sponsor
nCap Medical
Industry Sponsor
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