Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group 1 (Treatment)
Participants in Group 1 will have Leads placed by the nerves of the mid to upper thigh. These participants will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.
  • Device: SPRINT Peripheral Nerve Stimulation (PNS) System
    The SPRINT System delivers mild electrical stimulation to nerves in the affected limb. The SPRINT System includes two small wires (called "Leads") that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
    Other names:
    • SPRINT
    • SPRINT System
Sham Comparator
Group 2 (Control)
Participants in Group 2 will have Leads placed by the nerves of the mid to upper thigh. These participants will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and receive 8 weeks of sham stimulation. Participants will then have the option to crossover and receive stimulation therapy.
  • Device: SPRINT Peripheral Nerve Stimulation (PNS) System
    The SPRINT System delivers mild electrical stimulation to nerves in the affected limb. The SPRINT System includes two small wires (called "Leads") that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
    Other names:
    • SPRINT
    • SPRINT System

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Shellah Rogers
501-614-2086
SCRogers2@uams.edu

University of California San Diego
San Diego, California 92103
Contact:
Baharin Abdullah
858-344-4144
baabdullah@health.ucsd.edu

The Orthopaedic Institute
Gainesville, Florida 32607
Contact:
Carole Newell, RN
352-224-4904
cnewell@toi-health.com

NorthShore University HealthSystem
Evanston, Illinois 60201
Contact:
Candy Gonzalez
224-364-7456
cgonzalez@northshore.org

Ochsner Clinic Foundation
New Orleans, Louisiana 70115
Contact:
Kayla Barney
504-897-5844
kayla.barney@ochsner.org

Ali K. Valimahomed MD PLLC
Holmdel, New Jersey 07733
Contact:
Angela Sollitto
732-788-0349
angelas@gramercypaincenter.com

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Contact:
Michelle Becton
919-843-6575
michelle_becton@med.unc.edu

UT Health San Antonion
San Antonio, Texas 78229
Contact:
Robert Villarreal, MS
210-567-4527
VillarreaR10@uthscsa.edu

More Details

NCT ID
NCT04341948
Status
Recruiting
Sponsor
SPR Therapeutics, Inc.

Study Contact

Ryan Begun
844-378-9108
rbegun@sprtherapeutics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.