Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-06

Study Completion Date

2024-06-27

Brief Summary

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The purpose of this study is to gather information about how knee pain changes when small amounts of electricity are delivered to the nerves in the leg. This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The SPRINT PNS System was cleared by the FDA for up to 60 days of use in the back and/or extremities for the management of acute and chronic pain.

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Detailed Description

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Conditions

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Postoperative Pain Total Knee Replacement Total Knee Arthroplasty Partial Knee Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1 (Treatment)

Participants in Group 1 will have Leads placed by the nerves of the mid to upper thigh. These participants will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.

Group Type ACTIVE_COMPARATOR

SPRINT Peripheral Nerve Stimulation (PNS) System

Intervention Type DEVICE

The SPRINT System delivers mild electrical stimulation to nerves in the affected limb. The SPRINT System includes two small wires (called "Leads") that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).

Group 2 (Control)

Participants in Group 2 will have Leads placed by the nerves of the mid to upper thigh. These participants will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and receive 8 weeks of sham stimulation. Participants will then have the option to crossover and receive stimulation therapy.

Group Type SHAM_COMPARATOR

SPRINT Peripheral Nerve Stimulation (PNS) System

Intervention Type DEVICE

The SPRINT System delivers mild electrical stimulation to nerves in the affected limb. The SPRINT System includes two small wires (called "Leads") that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).

Interventions

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SPRINT Peripheral Nerve Stimulation (PNS) System

The SPRINT System delivers mild electrical stimulation to nerves in the affected limb. The SPRINT System includes two small wires (called "Leads") that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).

Intervention Type DEVICE

Other Intervention Names

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SPRINT SPRINT System

Eligibility Criteria

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Inclusion Criteria

* At least 21 years old
* Underwent a 1. primary total knee replacement (TKR), 2. secondary/revision TKR or 3. Partial/unicompartmental knee replacement (PKR)
* Knee pain directly resulting from Knee Replacement surgery in affected knee

Exclusion Criteria

* Current high opioid use
* Body Mass Index (BMI) \> 40 kg/m2
* Conditions with increased risk of infection
* Implanted electronic device
* History of bleeding or clotting disorder.
* Uncontrolled Diabetes Mellitus Types I or II
* Pregnancy

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No