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

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