NEUROCUPLE™ in TKA Patients
NCT Number: NCT06460350
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Total Knee Arthroplasty
Interventions: DEVICE: NEUROCUPLE™ Patch|DEVICE: Placebo Patch
Sponsor: nCap Medical
Collaborators: University of Pittsburgh
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT
Start Date: 2024-06-24
Completion Date: 2026-06-30
Locations: UPMC Shadyside Hospital, Pittsburgh, Pennsylvania, 15232, United States

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.

Primary Outcome Measures: Baseline 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, Prior to day of surgery|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|Opioid prescriptions within the first 6-weeks following surgery, The number of opioid refills will be collected via Prescription Drug Monitoring Program (PDMP) for up to 6-weeks following hospital discharge. This will be averaged across each group and reported as a Mean(SD)., 6-Weeks Post Hospital Discharge
Secondary Outcome Measures: Pain while walking 30 feet, baseline, Pain while walking 30 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable, Prior to day of surgery|Pain while walking 30 feet, 24-hours post-op, Pain while walking 30 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable, 24-hours post-operatively|Pain while walking 30 feet, 1-week post-op, Pain while walking 30 feet 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|Pain while walking 30 feet, 2-weeks post-op, Pain while walking 30 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable, 2-Weeks Post Hospital Discharge|Pain while walking 30 feet, 6-weeks post-op, Pain while walking 30 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable, 6-Weeks Post Hospital Discharge|Pain while walking 100 feet, baseline, Pain while walking 100 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable, Prior to day of surgery|Pain while walking 100 feet, 24-hours post-op, Pain while walking 100 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable, 24-hours post-operatively|Pain while walking 100 feet, 1-week post-op, Pain while walking 100 feet 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|Pain while walking 100 feet, 2-weeks post-op, Pain while walking 100 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable, 2-Weeks Post Hospital Discharge|Pain while walking 100 feet, 6-weeks post-op, Pain while walking 100 feet will be assessed by a numerical rate scale (NRS), in which 0 = no pain at all and 10 = the worst pain imaginable, 6-Weeks Post Hospital Discharge|Time to hospital discharge, The length of the hospital stay will be abstracted from the medical records and the averaged time \[mean(SD)\] will be reported in minutes., Up to post-operative day 7