NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty

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

Conditions

• Total Knee Arthroplasty Postoperative Pain
• Opioid Reduction After TKA

Interventions

DEVICE

NEUROCUPLE™ Patch

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 patch will be worn for 7-days

DEVICE

Sham patch

Non-active placebo patch visually identical to NEUROCUPLE™ worn for 7 days following total knee arthroplasty.

OTHER

Enhanced Recovery After Surgery (ERAS) Standard of Care

Participants in both arms will receive approved Enhanced Recovery After Surgery (ERAS) multimodal care, including preoperative education and optimization, intraoperative minimally invasive techniques and multimodal analgesia, and postoperative early mobilization, early nutrition, pain control, and monitoring for complications

Sponsors & Collaborators

• nCap Medical

  collaborator INDUSTRY

• Jacques E. Chelly

  lead OTHER

Principal Investigators

• Jacques E. Chelly, MD, PhD, MBA · University of Pittsburgh / UPMC

• Amy Monroe, MPH, MBA · University of Pittsburgh / UPMC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-12-31

Primary Completion

2027-08-31

Completion

2027-11-30

FDA Device

Yes

Countries

• United States

Study Locations