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Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) After Knee Surgery
Not Recruiting
Trial ID: NCT04670042
Purpose
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
Feasibility and Effectiveness of Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) Following Total Knee Arthroplasty.
Stanford Investigator(s)
Einar Ottestad
Clinical Professor, Anesthesiology, Perioperative and Pain Medicine
Eligibility
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
Intervention(s):
device: SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Einar Ottestad, MD