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

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04670042

Collaborator

SPR Therapeutics, Inc. (Industry)

Enrollment

Location

Arm

34.2

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Injury; Nerve, Peripheral, Multiple Chronic Post-Procedural Pain Total Knee Arthroplasty Surgery Knee Injuries Knee Pain Chronic Postoperative Pain Chronic Postoperative Pain	Device: SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 25, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared) Same as Arm Description.

Arm

Intervention/Treatment

Experimental: SPRINT® Peripheral Nerve Stimulation (PNS) System

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

Same as Arm Description.

Outcome Measures

Primary Outcome Measures

Change in Pain Intensity from Baseline to 12 Months [Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA]
The primary outcome is Pain Intensity using Numerical Rating Scale (NRS) from 0-10 with the higher number (10) being worse pain and (0) being no pain. Incidence of chronic post-surgical pain (CPSP) through Pain Intensity will be looked at for patients throughout the study along with usage of the Peripheral Nerve Stimulation (PNS) device (hours/day). A collection of surveys already approved for patients following total knee arthroplasty from Stanford's Collaborative Health Outcomes Information Registry (CHOIR) will also be sent to patients.

Secondary Outcome Measures

Change in Opioid Use [Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA]
Opioid use as documented in the medical records and patient-reported. Will note the increase, decrease, or no change in opioid associated with implantation of the study device.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Pain that continues or is expected to continue for longer than 3 months from its initial onset or
Persistent pain that at the discretion of the physician has not resolved within the normal time course of healing or
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