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

Stanford University

Status: Withdrawn

Conditions: Postoperative Pain; Knee Injuries; Surgery; Chronic Postoperative Pain; Chronic Post-Procedural Pain; Injury; Nerve, Peripheral, Multiple; Knee Pain Chronic; Total Knee Arthroplasty

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04670042

58819

Details and patient eligibility

About

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.

Sex: All

Ages: 21+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

SPRINT® Peripheral Nerve Stimulation (PNS) System

Experimental group

Description:

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.

Treatment:

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