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

SPR Therapeutics

Status: Completed

Conditions: Postoperative Pain; Partial Knee Replacement; Total Knee Arthroplasty; Total Knee Replacement

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

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT04341948

CDMRP-OR170165 (Other Grant/Funding Number)

0150-CSP-000

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Group 1 (Treatment)

Active Comparator group

Description:

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.

Treatment:

Device: SPRINT Peripheral Nerve Stimulation (PNS) System

Group 2 (Control)

Sham Comparator group

Description:

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.

Treatment:

Device: SPRINT Peripheral Nerve Stimulation (PNS) System