NEUROCUPLE™ in TKA Patients to Enhance Pain Management

NCT06460350 | Completed DMC FDA Device

• 1 other identifier: STUDY24020075
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty

Keywords

Total Joint Arthroplasty; Total Knee Arthroplasty; Postoperative Pain; Nanotechnology-Based Device (NBD); Ambulatory Total Knee Arthroplasty; Opioid

Outcome Measures

Primary Outcomes (1)

• Post-operative pain at rest

  Pain at rest will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable

  1-Week Post Hospital Discharge

Secondary Outcomes (5)

• Post-Operative Nausea and Vomiting

  Up to 24-hours post-operatively

• Time to hospital discharge (length of hospital stay)

  Up to post-operative day 7

• Total Opioid Use in OME (mg) (in hospital)

  Up to 24-hours post-operatively

• Total Opioid Use in OME (mg) at 1 week

  One-week Post Hospital Discharge

• Post-Operative pain scores (NRS)

  Up to 24-hours post-operatively

Other Outcomes (14)

• Baseline pain at rest

  Prior to day of surgery

• Pain while walking 30 feet, baseline

  Prior to day of surgery

• Pain while walking 30 feet, 1-week post-op

  1-Week Post Hospital Discharge

Study Arms (2)

NEUROCUPLE™ Group

EXPERIMENTAL

This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 2-weeks following their TKA surgery.

Device: NEUROCUPLE™ Patch

Placebo Group

PLACEBO COMPARATOR

This arm of subjects will receive the placebo (non-active, sham) patch to wear for 2-weeks following their TKA surgery.

Device: Placebo Patch

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.

NEUROCUPLE™ Group

Placebo Patch DEVICE

The placebo patch is identical to the active patch but with no active agents.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Scheduled for elective primary unilateral TKA
• T-score \< 60 on the PROMIS Anxiety measure

You may not qualify if:

• 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

Sponsors & Collaborators

• nCap Medical: lead
• University of Pittsburgh: collaborator

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jacques E. Chelly, MD, PhD, MBA

  University of Pittsburgh / UPMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a double-blinded randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of a 2-week application of the NEUROCUPLE device for pain relief and reduction of opioid refills after TKA. We have a placebo device (sham device without the captor array layer) that looks exactly like the active device, allowing us to conduct a true placebo-controlled randomized study. The trial will include 140 participants over a 1-year period.

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: September 25, 2024
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)