Clinical trial NCT04341948: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: SPR Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2020-04-10
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction in average pain intensity
timeFrame: Baseline and 5-weeks post-Start of Treatment (SOT) thru 8-weeks post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: During Lead placement at SOT
measure: Study-Related Adverse Device Effects
timeFrame: 24-48 hours post-Lead placement
measure: Study-Related Adverse Device Effects
timeFrame: 1-week post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: 2-weeks post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: 3-weeks post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: 4-weeks post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: 5-weeks post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: 6-weeks post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: 7-weeks post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: 8-weeks post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: 3-months post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: 6-months post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: 9-months post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: 12-months post-SOT
measure: Study-Related Adverse Device Effects
timeFrame: During Lead placement at Start of optional Crossover Treatment (SOCT)
measure: Study-Related Adverse Device Effects
timeFrame: 24-48 hours post-Lead placement SOCT
measure: Study-Related Adverse Device Effects
timeFrame: 2-weeks post-SOCT
measure: Study-Related Adverse Device Effects
timeFrame: 4-weeks post-SOCT
measure: Study-Related Adverse Device Effects
timeFrame: 8-weeks post-SOCT
measure: Study-Related Adverse Device Effects
timeFrame: 3-months post-SOCT
measure: Study-Related Adverse Device Effects
timeFrame: 6-months post-SOCT
measure: Study-Related Adverse Device Effects
timeFrame: 9-months post-SOCT
measure: Study-Related Adverse Device Effects
timeFrame: 12-months post-SOCT
Secondary outcomes:
measure: Average pain intensity
timeFrame: Baseline, 1-week post-SOT thru 4-weeks post-SOT
measure: Mean pain relief
timeFrame: 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
measure: Long-term durability of average pain intensity
timeFrame: Baseline, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT
measure: Pain medication usage
timeFrame: 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
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 4-weeks post-SOT, 8-weeks post-SOT
measure: Patient Global Impression of Change (PGIC)
timeFrame: 4-weeks post-SOT, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT
measure: Pain interference
timeFrame: Baseline, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT
measure: Function (i.e. physical recovery)
timeFrame: Baseline, 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, 12-months post-SOT
measure: Six Minute Walk Test (6MWT)
timeFrame: Baseline, 8-weeks post-SOT, 3-months post-SOT
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Gainesville
country: United States
facility: The Orthopaedic Institute
state: Florida
city: Newnan
country: United States
facility: Better Health Clinical Research, Inc
state: Georgia
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Holmdel
country: United States
facility: Ali K. Valimahomed MD PLLC
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: San Antonio
country: United States
facility: UT Health San Antonio
state: Texas
Study officials:
References: