Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System

Status:	Recruiting
Conditions:	Chronic Pain, Post-Surgical Pain, Orthopedic, Orthopedic
Therapuetic Areas:	Musculoskeletal, Orthopedics / Podiatry
Healthy:	No
Age Range:	21 - 90
Updated:	4/6/2019
Start Date:	September 5, 2017
End Date:	December 2019

A Prospective, Comparative Effectiveness Randomized Controlled Trial 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) in addition to the standard of care can safely and effectively reduce pain
following total knee replacement more than the standard of care, alone. This study involves a
device called the SPRINT Beta System. The SPRINT Beta System delivers mild electrical
stimulation to nerves in the leg that received the knee replacement. The SPRINT Beta 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 Beta
Stimulator). About half the subjects in this study will receive the SPRINT Beta system
(treatment group) and half will not (control group). Both groups will receive the standard of
care.

Key Inclusion Criteria:

- Scheduled to undergo a primary unilateral total knee replacement procedure

Key Exclusion Criteria:

- Body Mass Index > 40 kg/m2

- Conditions that place the subject at increased risk of infection

- History of valvular heart disease

- Implanted electronic device

- 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