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

Study Overview
=================
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.

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

Conditions
-----------------
Postoperative Pain, Total Knee Replacement, Total Knee Arthroplasty, Partial Knee Replacement

Intervention / Treatment
-----------------
* Device: SPRINT Peripheral Nerve Stimulation (PNS) System


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (Treatment)<br>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<br>* 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).<br>* Other names: SPRINT System;|
| Sham Comparator: Group 2 (Control)<br>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<br>* 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).<br>* Other names: 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Postoperative, Musculoskeletal Diseases, Postoperative Complications, Nervous System Diseases, Pain, Neurologic Manifestations, Signs and Symptoms