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

SPR Therapeutics

Status: Completed

Conditions: Postoperative Pain; Orthopedic Disorders; Pain; Total Knee Arthroplasty; Total Knee Replacement

Treatments: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02468934

0141-CSP-000

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Peripheral Nerve Stimulation

Experimental group

Description:

All study subjects will have up to 2 Smartpatch Leads placed in their leg that underwent total knee replacement, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.

Treatment:

Device: SPRINT Peripheral Nerve Stimulation (PNS) System