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

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.

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