NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty

Conditions

• Opioid Reduction After TKA
• Total Knee Arthroplasty Postoperative Pain

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• NEUROCUPLE™ Patch — DEVICE
  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
• Sham patch — DEVICE
  Non-active placebo patch visually identical to NEUROCUPLE™ worn for 7 days following total knee arthroplasty.
• Enhanced Recovery After Surgery (ERAS) Standard of Care — OTHER
  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

Study Details

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

Key Dates

Start date

May 31, 2026

Status verified

Mar 2026

Primary completion

Nov 30, 2026

Completion

Nov 30, 2027

Study Design

Enrollment

274 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: NEUROCUPLE™ Group
  This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 7 days following their TKA surgery.
• Sham Comparator: Sham Group
  This arm of subjects will receive the placebo (non-active, sham) patch to wear for 7 days following their TKA surgery.

Primary Outcome Measure

Opioid Consumption [ Time Frame: 0- 24 hours post-surgery ]

Central Contacts

• Jacques E. Chelly, MD, PhD, MBA
  (412)623-6904
  [email protected]
• Dayana Alsamsam, BSPS, MSc
  412-123-4567
  [email protected]

Locations (3)

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