Treatment of Post-Operative Pain Following Orthopedic Surgery With SPRINT® Peripheral Nerve Stimulation (PNS) System
2 other identifiers
interventional
56
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable postoperative-pain
Started Aug 2020
Longer than P75 for not_applicable postoperative-pain
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2020
CompletedFirst Posted
Study publicly available on registry
April 10, 2020
CompletedStudy Start
First participant enrolled
August 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2024
CompletedResults Posted
Study results publicly available
August 27, 2025
CompletedAugust 27, 2025
August 1, 2025
3.9 years
April 7, 2020
June 26, 2025
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduction in Average Pain Intensity: Number of Participants With ≥ 50% Reduction in Average Pain Intensity
All participants were asked to complete daily diaries to record their average knee pain during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average pain scores were calculated across the 7-day diary(s) at baseline and across weeks 5 to 8 post-start of treatment. Percent reduction was then calculated for each participant. To be considered a success, participants must have experienced ≥ 50% reduction in average knee pain. The number of successes is presented.
Baseline and 5 to 8 weeks post-Start of Treatment (SOT)
Study-Related Adverse Device Effects
At each study visit following the baseline assessment at Visit 1, participants were questioned if any changes in their medical status or condition have occurred since their previous visit. If the participant experienced a change that was a study-related adverse event, an Adverse Event Form was completed by the site. The number of participants that experienced at least one study-related adverse event is reported here. Adverse Events are reported by the trial phase in which they occurred: Group 1 Treatment (active stimulation), Group 2 Control (sham stimulation), and Group 2 Crossover Safety Set (active stimulation).
Up to 13 months for each Group 1 participant and up to 16 months for Group 2 participants that opted to cross over (time from baseline to last study visit)
Secondary Outcomes (9)
Reduction in Average Pain Intensity: Number of Participants With ≥ 50% Reduction in Average Pain Intensity
Baseline and 1 to 4-weeks post-start of treatment (SOT)
Long-term Durability of Average Pain Relief: Number of Participants With ≥ 50% Reduction in Average Pain Intensity
Baseline, 3-months post-start of treatment (SOT), 6-months post-SOT, 9-months post-SOT, 12-months post-SOT
Mean Pain Relief
Baseline, 1 to 4-weeks post-start of treatment (SOT), 5 to 8-weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, and 12-months post-SOT
Pain Medication Usage
Baseline, 1 to 4 weeks post-start of treatment (SOT), and 5 to 8 weeks post-SOT, 3-months post-SOT, 6-months post-SOT, 9-months post-SOT, and 12-months post-SOT
Pain Catastrophizing Scale (PCS)
Baseline (Visit 1), 4-weeks post-SOT (Visit 6), and 8-weeks post-SOT (Visit 10)
- +4 more secondary outcomes
Study Arms (2)
Group 1 (Treatment)
ACTIVE COMPARATORParticipants 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.
Group 2 (Control)
SHAM COMPARATORParticipants 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SPR Therapeutics, Inc.lead
- United States Department of Defensecollaborator
Study Sites (10)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
University of California San Diego
San Diego, California, 92103, United States
The Orthopaedic Institute
Gainesville, Florida, 32607, United States
Better Health Clinical Research, Inc
Newnan, Georgia, 30265, United States
NorthShore University HealthSystem
Evanston, Illinois, 60201, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70115, United States
Ali K. Valimahomed MD PLLC
Holmdel, New Jersey, 07733, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27710, United States
UT Health San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Affairs
- Organization
- SPR
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2020
First Posted
April 10, 2020
Study Start
August 6, 2020
Primary Completion
June 27, 2024
Study Completion
June 27, 2024
Last Updated
August 27, 2025
Results First Posted
August 27, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share