Total Knee Arthroplasty Clinical Trial
Official title:
Enhancing Pain Management for Knee Replacement Patients Through an Innovative Non-invasive and Opioid-sparing Device (NEUROCUPLE™)
Verified date | June 2024 |
Source | nCap Medical |
Contact | Anthony Sutera |
Phone | 801-566-4124 |
tsutera[@]ncap.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 140 |
Est. completion date | June 30, 2026 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - >18 years of age - Scheduled for elective primary unilateral TKA Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | UPMC Shadyside Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
nCap Medical | University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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