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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Same as Arm Description.
Stanford Pain Management Center
Redwood City, California, United States
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.
Time frame: Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA
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.
Time frame: Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA
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