Summary

for people ages 21-90 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:
Brian Ilfeld

Description

Summary

The purpose of this study is to determine if electrical stimulation (small levels of electricity) in addition to the standard of care can safely and effectively reduce pain following total knee replacement more than the standard of care, alone. This study involves a device called the SPRINT Beta System. The SPRINT Beta System delivers mild electrical stimulation to nerves in the leg that received the knee replacement. The SPRINT Beta System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Beta Stimulator). About half the subjects in this study will receive the SPRINT Beta system (treatment group) and half will not (control group). Both groups will receive the standard of care.

Official Title

A Prospective, Comparative Effectiveness Randomized Controlled Trial of SPR Peripheral Nerve Stimulation (PNS) Therapy for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Utilizing Preoperative Lead Placement

Keywords

Total Knee Replacement Total Knee Arthroplasty Pain Postoperative Pain Orthopedic Disorder electrical stimulation neurostimulation TKA pain pain following total knee replacement Pain, Postoperative Musculoskeletal Diseases SPRINT Beta System

Eligibility

For people ages 21-90

Key Inclusion Criteria:

  • Scheduled to undergo a primary unilateral total knee replacement procedure

Key Exclusion Criteria:

  • Body Mass Index > 40 kg/m2
  • Conditions that place the subject at increased risk of infection
  • History of valvular heart disease
  • Implanted electronic device
  • Bleeding disorder
  • Allergy to skin surface electrodes and/or medical-grade adhesive tapes
  • Pregnant

Locations

  • University of California San Diego accepting new patients
    La Jolla California 92037 United States
  • HD Research accepting new patients
    Houston Texas 77004 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SPR Therapeutics, Inc.
ID
NCT03286543
Lead Scientist
Brian Ilfeld
Study Type
Interventional
Last Updated
September 25, 2018