CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 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/NCT04341948
NCT04341948N/ACompleted
CompareCT.gov

Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System in a Randomized, Double-Blinded, Placebo-Controlled Trial

SPR Therapeutics, Inc.·interventional·Posted Apr 10, 2020·Updated Aug 27, 2025

In Brief

A clinical study evaluating SPRINT Peripheral Nerve Stimulation (PNS) System for Postoperative Pain and 3 related conditions. Completed, enrolled 56 participants across 10 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain, Total Knee Replacement, Total Knee Arthroplasty, Partial Knee Replacement
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 10, 2020
Enrollment StartAug 6, 2020
Primary CompletionJun 27, 2024
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 6.2 years ago

Interventions

SPRINT Peripheral Nerve Stimulation (PNS) Systemdevice

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).