NCT02468934

Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Using the SPRINT System

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: SPR Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Total Knee Replacement
• Total Knee Arthroplasty
• Pain
• Postoperative Pain
• Orthopedic Disorders

Interventions

Type	Name	Description
DEVICE	SPRINT Peripheral Nerve Stimulation (PNS) System	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).

Timeline

• Start date: 2015-10-22
• Primary completion: 2017-07-17
• Completion: 2017-07-17
• First posted: 2015-06-11
• Last updated: 2018-09-04
• Results posted: 2018-09-04

Locations

3 sites across 1 country: United States