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

• ClinicalTrials.gov Identifier: NCT04341948
• Recruitment Status: Active, not recruiting
• First Posted: April 10, 2020
• Last Update Posted: December 19, 2023
• Sponsor: SPR Therapeutics, Inc.
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): SPR Therapeutics, Inc.

Tracking Information

• First Submitted Date: April 7, 2020
• First Posted Date: April 10, 2020
• Last Update Posted Date: December 19, 2023
• Actual Study Start Date: August 6, 2020
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 7, 2020)

• Reduction in average pain intensity [ Time Frame: 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).
• Study-Related Adverse Device Effects [ Time Frame: During Lead placement at SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 24-48 hours post-Lead placement ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 1-week post-SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 2-weeks post-SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 3-weeks post-SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 4-weeks post-SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 5-weeks post-SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 6-weeks post-SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 7-weeks post-SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 8-weeks post-SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 3-months post-SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 6-months post-SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 9-months post-SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 12-months post-SOT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: During Lead placement at Start of optional Crossover Treatment (SOCT) ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 24-48 hours post-Lead placement SOCT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 2-weeks post-SOCT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 4-weeks post-SOCT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 8-weeks post-SOCT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 3-months post-SOCT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 6-months post-SOCT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 9-months post-SOCT ]
  Occurrence and type of study-related AEs
• Study-Related Adverse Device Effects [ Time Frame: 12-months post-SOCT ]
  Occurrence and type of study-related AEs

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 7, 2020)

• Average pain intensity [ Time Frame: Baseline, 1-week post-SOT thru 4-weeks post-SOT ]
  Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).
• Mean pain relief [ Time Frame: 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).
• Long-term durability of average pain intensity [ Time Frame: 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).
• Pain medication usage [ Time Frame: 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
• Pain Catastrophizing Scale (PCS) [ Time Frame: 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).
• Patient Global Impression of Change (PGIC) [ Time Frame: 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.
• Pain interference [ Time Frame: 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).
• Function (i.e. physical recovery) [ Time Frame: 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).
• Six Minute Walk Test (6MWT) [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System
• Official Title: Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System in a Randomized, Double-Blinded, Placebo-Controlled Trial
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

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

Intervention

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

Study Arms

• 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.
  Intervention: Device: SPRINT Peripheral Nerve Stimulation (PNS) 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.
  Intervention: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 21, 2023): 56
• Original Estimated Enrollment (submitted: April 7, 2020): 150
• Estimated Study Completion Date: July 2024
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04341948
• Other Study ID Numbers: 0150-CSP-000; CDMRP-OR170165 ( Other Grant/Funding Number: Department of Defense )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: SPR Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: SPR Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: United States Department of Defense
• Investigators: Not Provided
• PRS Account: SPR Therapeutics, Inc.
• Verification Date: December 2023