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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Pain; Total Knee Arthroplasty; Total Knee Replacement; Partial Knee Replacement
• Intervention / Treatment: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ryan Begun; Phone Number: 844-378-9108; Email: rbegun@sprtherapeutics.com

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • California
    • San Diego, California, United States, 92103
      • University of California San Diego
  • Florida
    • Gainesville, Florida, United States, 32607
      • The Orthopaedic Institute
  • Georgia
    • Newnan, Georgia, United States, 30265
      • Better Health Clinical Research, Inc
  • Illinois
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Ochsner Clinic Foundation
  • New Jersey
    • Holmdel, New Jersey, United States, 07733
      • Ali K. Valimahomed MD PLLC
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill
    • Durham, North Carolina, United States, 27710
      • Duke University
  • Texas
    • San Antonio, Texas, United States, 78229
      • UT Health San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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).; Other Names: SPRINT; SPRINT System
Sham Comparator: 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.	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).; Other Names: SPRINT; SPRINT System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in average pain intensity	Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).	Baseline and 5-weeks post-Start of Treatment (SOT) thru 8-weeks post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	During Lead placement at SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	24-48 hours post-Lead placement
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	1-week post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	2-weeks post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	3-weeks post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	4-weeks post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	5-weeks post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	6-weeks post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	7-weeks post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	8-weeks post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	3-months post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	6-months post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	9-months post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	12-months post-SOT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	During Lead placement at Start of optional Crossover Treatment (SOCT)
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	24-48 hours post-Lead placement SOCT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	2-weeks post-SOCT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	4-weeks post-SOCT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	8-weeks post-SOCT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	3-months post-SOCT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	6-months post-SOCT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	9-months post-SOCT
Study-Related Adverse Device Effects	Occurrence and type of study-related AEs	12-months post-SOCT

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SPR Therapeutics, Inc.
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2020
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 7, 2020
• First Submitted That Met QC Criteria: April 7, 2020
• First Posted (Actual): April 10, 2020

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Nervous System Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Postoperative Complications; Signs and Symptoms; Pain, Postoperative
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 0150-CSP-000; CDMRP-OR170165 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No