NCT04341948

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

Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System in a Randomized, Double-Blinded, Placebo-Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: SPR Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Postoperative Pain
• Total Knee Replacement
• Total Knee Arthroplasty
• Partial Knee Replacement

Interventions

Type	Name	Description
DEVICE	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).

Timeline

• Start date: 2020-08-06
• Primary completion: 2024-06-27
• Completion: 2024-06-27
• First posted: 2020-04-10
• Last updated: 2025-08-27
• Results posted: 2025-08-27

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study