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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-05

Study Completion Date

2020-04-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Total Knee Replacement Total Knee Arthroplasty Pain Postoperative Pain Orthopedic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Half of the subjects enrolled will be randomized (like flipping a coin) to the treatment group and half will be randomized to the control group. Both groups will receive the standard of care for pain management following total knee replacement surgery. Subjects in the treatment group will receive SPR's SPRINT Beta Peripheral Nerve Stimulation (PNS) System in addition to standard of care.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group (SPRINT Beta System)

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.

Group Type EXPERIMENTAL

SPRINT Beta System

Intervention Type DEVICE

The SPRINT Beta System is an Investigational Device which delivers mild electrical stimulation to nerves in the leg that underwent lead placement. 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).

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SPRINT Beta System

The SPRINT Beta System is an Investigational Device which delivers mild electrical stimulation to nerves in the leg that underwent lead placement. 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).

Intervention Type DEVICE

Other Intervention Names

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SPRINT Beta Peripheral Nerve Stimulation (PNS) System SPRINT Peripheral Nerve Stimulation (PNS) System SPRINT System

Eligibility Criteria

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Inclusion Criteria

* Scheduled to undergo a primary unilateral total knee replacement procedure

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No