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Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) After Knee Surgery | Clinical Trials | Clareo Health

WITHDRAWNNA

Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) After Knee Surgery

Feasibility and Effectiveness of Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) Following Total Knee Arthroplasty.

NCT04670042•Stanford University

View on ClinicalTrials.gov

Summary

SPRINT PNS System will be offered to patients with postoperative knee pain following primary unilateral total knee arthroplasty (TKA) who meet eligibility criteria and consistent with established coverage policy. SPRINT PNS System will be implanted for 60 days. At the discretion of the physician, the first lead may be placed to stimulate the nerve innervating the region of greatest pain. If pain is not adequately addressed by the first lead when assessed at 10 days, a second lead may be placed approximately 2 weeks following the initial lead placement.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At least 21 years old
•Underwent a primary or revision unilateral TKA
•Completed all CHOIR questionnaires before and after TKA surgery
•Persistent postsurgical knee pain ≥ 5 of 10 during ambulation as demonstrated on the CHOIR assessment.
•Must meet the definition of chronic pain.
•1. Pain that continues or is expected to continue for longer than 3 months from its initial onset or
•2. Persistent pain that at the discretion of the physician has not resolved within the normal time course of healing or
•3. Pain requiring opioid use beyond 30 days.

Exclusion Criteria

•Patients with a pre-operative history of moderate to high dose use of opioids (≥ 50 morphine milligram equivalents (MME) average per day)
•Patients taking opioids for reasons other than pain in knee that underwent TKA
•Patients with arthrofibrosis or indicated for manipulation under anesthesia
•BMI \>35
•Uncontrolled Diabetes Mellitus Types I or II, indicated by an HbA1c \>7.0% within the last 3 months
•Vulnerable population (e.g. pregnant women, prisoners, minors, or employees)
•Deep brain stimulation (DBS) system, an implanted active cardiac implant, or any other implantable neurostimulator whose stimulus current pathway may overlap the SPRINT stimulator's current pathway.
•Any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement, nerve damage in affected leg, pain caused by knee implant requiring revision, compromised immune system) as determined by the Investigator
•Workers Compensation

Locations (1)

Stanford Pain Management Center

Redwood City, California, United States

Key Dates

Start Date

June 25, 2021

Primary Completion Date

August 1, 2022

Completion Date

May 1, 2024

Last Updated

October 20, 2022

Conditions

Injury; Nerve, Peripheral, MultipleChronic Post-Procedural PainTotal Knee ArthroplastySurgeryKnee InjuriesKnee Pain ChronicPostoperative PainChronic Postoperative Pain

Interventions

SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared)

DEVICE

Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome

NCT07456787

Total Knee Arthroplasty\(TKA\)Osteoartrosi

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RECRUITINGNA

Mako Cementless TKA vs Mako Cemented TKA

NCT06929871

Total Knee ReplacementTotal Knee Replacement Surgery+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) After Knee Surgery

Inclusion Criteria

Exclusion Criteria

Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome

Mako Cementless TKA vs Mako Cemented TKA

Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty

Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty

Simulation-Based Preoperative Education in Total Knee Arthroplasty

Investigating Patient Satisfaction With Smart Knee Implants