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

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty; Partial Knee Replacement; Postoperative Pain; Total Knee Replacement
• Interventions: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

• Registration Number: NCT04341948
• Lead Sponsor: SPR Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-07
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-10
• Study Start: 2020-08-06
• Status Verified: 2024-06
• Primary Completion: 2024-06-27
• Study Completion: 2024-06-27
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2 (Control)	SPRINT Peripheral Nerve Stimulation (PNS) System	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 1 (Treatment)	SPRINT Peripheral Nerve Stimulation (PNS) System	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.

Primary Outcome Measures

Name	Time	Method
Study-Related Adverse Device Effects	12-months post-SOCT	Occurrence and type of study-related AEs
Reduction in average pain intensity	Baseline and 5-weeks post-Start of Treatment (SOT) thru 8-weeks post-SOT	Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC)	4-weeks post-SOT, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT	PGIC assesses the patient's impression of change in quality of life.
Mean pain relief	Baseline, 1-week post-SOT thru 4-weeks post-SOT, 5-weeks post-SOT thru 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT	Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).
Pain Catastrophizing Scale (PCS)	Baseline, 4-weeks post-SOT, 8-weeks post-SOT	PCS is a 13-question instrument to assess rumination (4 questions), magnification (3 questions), and helplessness (6 questions).
Average pain intensity	Baseline, 1-week post-SOT thru 4-weeks post-SOT	Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).
Long-term durability of average pain intensity	Baseline, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT	Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).
Function (i.e. physical recovery)	Baseline, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT	Measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Pain interference	Baseline, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT	Measured using the average pain interference (question 9 from the Brief Pain Inventory-SF, BPI-9).
Pain medication usage	Baseline, 1-week post-SOT thru 4-weeks post-SOT, and 5-weeks post thru SOT-8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT	Medications collected for each diary collection period
Six Minute Walk Test (6MWT)	Baseline, 8-weeks post-SOT, 3-months post-SOT	The 6MWT measures the distance walked in 6 minutes and will be used to assess walking speed and endurance.

Trial Locations

Locations (10)

Ali K. Valimahomed MD PLLC; 🇺🇸 Holmdel, New Jersey, United States

Better Health Clinical Research, Inc; 🇺🇸 Newnan, Georgia, United States

The Orthopaedic Institute; 🇺🇸 Gainesville, Florida, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

UT Health San Antonio; 🇺🇸 San Antonio, Texas, United States