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 primary unilateral total knee replacement procedure - Knee pain directly resulting from Total Knee Replacement 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. - Surgery on the affected knee since the primary Total Knee Replacement - 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:
Alicia DeAguero, MS
501-214-2410
badeaguero@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:
Gretchen Kostedt, RN
352-336-6000
gkostedt@toi-health.com

Better Health Clinical Research, Inc
Newnan, Georgia 30265
Contact:
Debra Helton
770-252-7562
dhelton@gapaincare.com

NorthShore University HealthSystem
Evanston, Illinois 60201
Contact:
Daniel Amusin
847-570-3558
damusin@northshore.org

Ochsner Clinic Foundation
New Orleans, Louisiana 70115
Contact:
Colleen M. Dionne
504-894-2864
Colleen.dionne@ochsner.org

Ali K. Valimahomed MD PLLC
Holmdel, New Jersey 07733
Contact:
Alexandria Nuwar
732-784-7151

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

Duke University
Durham, North Carolina 27710
Contact:
Dan Mungal, BA
919-613-2609
daniel.mungal@duke.edu

More Details

NCT ID
NCT04341948
Status
Recruiting
Sponsor
SPR Therapeutics, Inc.

Study Contact

Elizabeth Deyling
844-378-9108
edeyling@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.