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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-25

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Case series of 15 subjects with chronic post-surgical pain (CPSP). Subjects will be recruited over 6 months (on average 1 subject per week)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SPRINT® Peripheral Nerve Stimulation (PNS) System

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.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

Same as Arm Description.

Interventions

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

Same as Arm Description.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No