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

SPR Therapeutics

Status: Completed

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

Treatments: Device: SPRINT Beta System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03286543

0144-CSP-000

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 21 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Treatment Group (SPRINT Beta System)

Experimental group

Description:

Subjects in the treatment group will have up to 2 leads placed in their leg that underwent total knee replacement, will use the SPRINT Beta System, and will receive electrical stimulation in addition to the standard of care.

Treatment:

Device: SPRINT Beta System

Control Group

No Intervention group

Description:

Subjects in the control group will receive the standard of care.