CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
SPRINT Peripheral Nerve Stimulation (PNS) Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02468934
NCT02468934N/ACompleted
CompareCT.gov

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

SPR Therapeutics, Inc.·interventional·Posted Jun 11, 2015·Updated Sep 4, 2018

In Brief

A clinical study evaluating SPRINT Peripheral Nerve Stimulation (PNS) System for Total Knee Replacement and 4 related conditions. Completed, enrolled 24 participants across 3 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTotal Knee Replacement, Total Knee Arthroplasty, Pain, Postoperative Pain, Orthopedic Disorders
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 11, 2015
Enrollment StartOct 22, 2015
Primary CompletionJul 17, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.1 years ago

Interventions

SPRINT Peripheral Nerve Stimulation (PNS) Systemdevice

The SPRINT System is an Investigational Device which delivers mild electrical stimulation to nerves in the leg that underwent lead placement. 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).