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

Study Overview
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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.

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

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

Intervention / Treatment
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* Device: SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared)


Participation Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPRINT® Peripheral Nerve Stimulation (PNS) System<br>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)<br>* Same as Arm Description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Intensity from Baseline to 12 Months | 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. | Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Opioid Use | 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. | Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Pain Following Left Total Knee Arthroplasty, Chronic Pain Following Right Total Knee Arthroplasty