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

Status:	Completed
Conditions:	Chronic Pain, Post-Surgical Pain, Orthopedic, Orthopedic
Therapuetic Areas:	Musculoskeletal, Orthopedics / Podiatry
Healthy:	No
Age Range:	21 - Any
Updated:	9/5/2018
Start Date:	October 22, 2015
End Date:	July 17, 2017

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

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).

Key Inclusion Criteria:

- At least 21 years old

- Scheduled to undergo a primary unilateral total knee replacement procedure

Key Exclusion Criteria:

- Body Mass Index (BMI) > 40 kg/m2

- Compromised immune system based on medical history

- History of valvular heart disease

- Implanted electronic device

- Joint or overlying skin infection of the affected limb

- History of recurrent skin infections

- Bleeding disorder

- Allergy to skin surface electrodes and/or medical‐grade adhesive tapes

- Pregnant

We found this trial at

sites

Duke Univ Med Ctr

2301 Erwin Rd
Durham, North Carolina 27710

919-684-8111