Completed

A Prospective Case Series Study of SPR Peripheral Nerve Stimulation (PNS) Therapy for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Utilizing Preoperative Lead Placement

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What is being tested

SPRINT Peripheral Nerve Stimulation (PNS) System

Device
Who is being recruted

Musculoskeletal Diseases+5

+ Neurologic Manifestations

+ Pain

Over 21 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: October 2015
See protocol details

Summary

Principal SponsorSPR Therapeutics, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 22, 2015

Actual date on which the first participant was enrolled.

The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce pain following total knee replacement (or total knee arthroplasty (TKA)). This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the leg that received the knee replacement. The SPRINT 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 Stimulator).

Official TitleA Prospective Case Series Study of SPR Peripheral Nerve Stimulation (PNS) Therapy for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Utilizing Preoperative Lead Placement
NCT02468934
Principal SponsorSPR Therapeutics, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Musculoskeletal DiseasesNeurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

9 exclusion criteria prevent from participating
Body Mass Index (BMI) > 40 kg/m2
Compromised immune system based on medical history
History of valvular heart disease
Implanted electronic device
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
All study subjects will have up to 2 Smartpatch Leads placed in their leg that underwent total knee replacement, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

University of California San Diego

La Jolla, United StatesOpen University of California San Diego in Google Maps
Suspended

Duke University Medical Center

Durham, United States
Suspended

Joint Implant Surgeons

New Albany, United States
Completed3 Study Centers