Feasibility and Effectiveness of Using Peripheral Nerve Stimulation (PNS) to Treat Chronic Post-surgical Pain (CPSP) Following Total Knee Arthroplasty.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Pain Intensity from Baseline to 12 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared) (Device)
结局指标
主要结局
Change in Pain Intensity from Baseline to 12 Months
时间窗: 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.
次要结局
- Change in Opioid Use(Collected at baseline, 10, 30, 60, and 90 days post lead placement; and 6 months following TKA)
研究者
Einar Ottestad
Clinical Associate Professor
Stanford University