Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System

a study on Postoperative Pain Knee Replacement

Summary

Eligibility
for people ages 21 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Brian M. Ilfeld, MD, MS
Headshot of Brian M. Ilfeld
Brian M. Ilfeld

Description

Summary

The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg. This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The SPRINT PNS System was cleared by the FDA for up to 60 days of use in the back and/or extremities for the management of acute and chronic pain.

Official Title

Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System in a Randomized, Double-Blinded, Placebo-Controlled Trial

Keywords

Postoperative Pain, Total Knee Replacement, Total Knee Arthroplasty, Partial Knee Replacement, Pain, Postoperative, Musculoskeletal Diseases, Postoperative Complications, Nervous System Diseases, Pain, Neurologic Manifestations, Signs and Symptoms, SPRINT Peripheral Nerve Stimulation (PNS) System

Eligibility

You can join if…

Open to people ages 21 years and up

  • At least 21 years old
  • Underwent a 1. primary total knee replacement (TKR), 2. secondary/revision TKR or 3. Partial/unicompartmental knee replacement (PKR)
  • Knee pain directly resulting from Knee Replacement surgery in affected knee

You CAN'T join if...

  • Current high opioid use
  • Body Mass Index (BMI) > 40 kg/m2
  • Conditions with increased risk of infection
  • Implanted electronic device
  • History of bleeding or clotting disorder.
  • Uncontrolled Diabetes Mellitus Types I or II
  • Pregnancy

Locations

  • University of California San Diego accepting new patients
    San Diego California 92103 United States
  • UT Health San Antonion accepting new patients
    San Antonio Texas 78229 United States

Lead Scientist at UCSD

  • Brian M. Ilfeld, MD, MS
    Professor In Residence, Anesthesiology, Vc-health Sciences-schools. Authored (or co-authored) 199 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SPR Therapeutics, Inc.
ID
NCT04341948
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated
Contact us about this trial