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

Primary Purpose

Postoperative Pain, Total Knee Replacement, Total Knee Arthroplasty

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPRINT Peripheral Nerve Stimulation (PNS) System
Sponsored by
SPR Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Pain, Postoperative, Musculoskeletal Diseases, Postoperative Complications, Nervous System Diseases, Pain, Neurologic Manifestations, Signs and Symptoms

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences
  • University of California San Diego
  • The Orthopaedic Institute
  • Better Health Clinical Research, Inc
  • NorthShore University HealthSystem
  • Ochsner Clinic Foundation
  • Ali K. Valimahomed MD PLLC
  • University of North Carolina at Chapel Hill
  • Duke University
  • UT Health San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group 1 (Treatment)

Group 2 (Control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reduction in average pain intensity
Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs
Study-Related Adverse Device Effects
Occurrence and type of study-related AEs

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2020
Last Updated
September 21, 2023
Sponsor
SPR Therapeutics, Inc.
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04341948
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 6, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SPR Therapeutics, Inc.
Collaborators
United States Department of Defense

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Total Knee Replacement, Total Knee Arthroplasty, Partial Knee Replacement
Keywords
Pain, Postoperative, Musculoskeletal Diseases, Postoperative Complications, Nervous System Diseases, Pain, Neurologic Manifestations, Signs and Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (Treatment)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2 (Control)
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
SPRINT Peripheral Nerve Stimulation (PNS) System
Other Intervention Name(s)
SPRINT, SPRINT System
Intervention Description
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).
Primary Outcome Measure Information:
Title
Reduction in average pain intensity
Description
Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).
Time Frame
Baseline and 5-weeks post-Start of Treatment (SOT) thru 8-weeks post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
During Lead placement at SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
24-48 hours post-Lead placement
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
1-week post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
2-weeks post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
3-weeks post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
4-weeks post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
5-weeks post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
6-weeks post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
7-weeks post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
8-weeks post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
3-months post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
6-months post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
9-months post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
12-months post-SOT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
During Lead placement at Start of optional Crossover Treatment (SOCT)
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
24-48 hours post-Lead placement SOCT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
2-weeks post-SOCT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
4-weeks post-SOCT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
8-weeks post-SOCT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
3-months post-SOCT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
6-months post-SOCT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
9-months post-SOCT
Title
Study-Related Adverse Device Effects
Description
Occurrence and type of study-related AEs
Time Frame
12-months post-SOCT
Secondary Outcome Measure Information:
Title
Average pain intensity
Description
Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).
Time Frame
Baseline, 1-week post-SOT thru 4-weeks post-SOT
Title
Mean pain relief
Description
Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).
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
Title
Long-term durability of average pain intensity
Description
Average pain intensity (Question 5 from the Brief Pain Inventory- Short Form, BPI-5).
Time Frame
Baseline, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT
Title
Pain medication usage
Description
Medications collected for each diary collection period
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
Title
Pain Catastrophizing Scale (PCS)
Description
PCS is a 13-question instrument to assess rumination (4 questions), magnification (3 questions), and helplessness (6 questions).
Time Frame
Baseline, 4-weeks post-SOT, 8-weeks post-SOT
Title
Patient Global Impression of Change (PGIC)
Description
PGIC assesses the patient's impression of change in quality of life.
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
Title
Pain interference
Description
Measured using the average pain interference (question 9 from the Brief Pain Inventory-SF, BPI-9).
Time Frame
Baseline, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT
Title
Function (i.e. physical recovery)
Description
Measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
Time Frame
Baseline, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT
Title
Six Minute Walk Test (6MWT)
Description
The 6MWT measures the distance walked in 6 minutes and will be used to assess walking speed and endurance.
Time Frame
Baseline, 8-weeks post-SOT, 3-months post-SOT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
The Orthopaedic Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Better Health Clinical Research, Inc
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Ali K. Valimahomed MD PLLC
City
Holmdel
State/Province
New Jersey
ZIP/Postal Code
07733
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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