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| Name | Class |
|---|---|
| nCap Medical | INDUSTRY |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEUROCUPLE™ Group | Experimental | This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 7 days following their TKA surgery. |
|
| Sham Group | Sham Comparator | This arm of subjects will receive the placebo (non-active, sham) patch to wear for 7 days following their TKA surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Total opioid consumption, expressed in milligrams of morphine equivalents (MME), during the first 24 hours following surgery. Opioid use will be calculated using all available data sources, including in-hospital medication administration records and, when applicable, the state Prescription Drug Monitoring Program (PDMP). MME values will be compared between the NEUROCUPLE™ patch group and the placebo patch group. Lower MME values indicate reduced opioid requirements and may reflect improved postoperative pain control, while higher MME values suggest increased opioid use and potentially greater pain or slower recovery. | 0- 24 hours post-surgery |
| Pain at Rest Using Numerical Rating Scale (NRS) | Pain at rest during the first 24 hours after surgery will be assessed using a Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain) and compared between the NEUROCUPLE™ patch group and the placebo patch group. Higher scores indicate worse pain | 0-24 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores Using Numerical Rating Scale (NRS) at Rest and during Movement | Pain will be assessed using a Numerical Rating Scale (0 = no pain, 10 = worst pain) at rest and during movement on postoperative Days 2 and 7. Higher scores indicate worse pain. | Post-operative at Day 2 and Day 7 |
| Patient Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacques E. Chelly, MD, PhD, MBA | Contact | (412)623-6904 | ChelJE@anes.upmc.edu | |
| Dayana Alsamsam, BSPS, MSc | Contact | 412-123-4567 | alsamsamd@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jacques E. Chelly, MD, PhD, MBA | University of Pittsburgh / UPMC | Principal Investigator |
| Amy Monroe, MPH, MBA | University of Pittsburgh / UPMC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC East Hospital | Pittsburgh | Pennsylvania | 15146 | United States |
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This will be a double-blinded randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of a 7-day application of the NEUROCUPLE device for pain relief and reduction of opioid refills after TKA. There is a placebo device (sham device without the captor array layer) that looks exactly like the active device, allowing for a true placebo-controlled randomized study.
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|
| 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 |
|
Patient satisfaction with recovery and device use will be assessed on postoperative Day 7 using standardized questionnaires. Scores range from 0 to 10, where 0 indicates the lowest level of satisfaction and 10 indicates the highest. |
| at Post-operative Day 7 |
| Opioid Consumption | Total opioid consumption, expressed in milligrams of morphine equivalents (MME), will be recorded over the 7-day postoperative period. Opioid use will be calculated using all available data sources, including in-hospital medication administration records and the state Prescription Drug Monitoring Program (PDMP) when applicable. MME values will be compared between the NEUROCUPLE™ patch group and the placebo patch group. Lower MME values indicate reduced opioid requirements and may reflect improved postoperative pain control, whereas higher MME values suggest increased opioid use and potentially greater pain or slower recovery. | Post-Operative Day 0- Day 7 |
| Postoperative Adverse Events and Device-Related Side Effects | The incidence of postoperative adverse events, including any events determined to be related to the study device, will be recorded and compared between the treatment groups during the 7-day postoperative period. Lower incidence rates indicate fewer complications and a more favorable safety profile, whereas higher incidence rates suggest increased complications, potential device-related issues, or a less favorable safety profile. | Postoperative Days 0-7 |
| Incidence of postoperative nausea and/or vomiting (yes/no) | Incidence and severity of postoperative nausea and vomiting will be recorded over the 7-day postoperative period as (yes/no) and compared between groups. | Postoperative Days 0-7 |
| Postoperative Length of Stay | Length of hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge, will be recorded and compared between groups. Lower length of stay values indicate faster recovery, fewer complications, and earlier readiness for discharge. Higher length of stay values suggest slower recovery, increased complications, or higher postoperative symptom burden. | From the date of surgery until hospital discharge (within the 7-day study period) |
| UPMC Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | United States |
|
| UPMC Passavant Hospital | Pittsburgh | Pennsylvania | 15237 | United States |
|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000080482 | Enhanced Recovery After Surgery |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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