A Prospective Case Series Study of SPR Peripheral Nerve Stimulation (PNS) Therapy for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Utilizing Preoperative Lead Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Average Knee Pain While Walking
研究概览
简要总结
The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce pain following total knee replacement (or total knee arthroplasty (TKA)). This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the leg that received the knee replacement. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).
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
- •Scheduled to undergo a primary unilateral total knee replacement procedure
排除标准
- •Body Mass Index (BMI) > 40 kg/m2
- •Compromised immune system based on medical history
- •History of valvular heart disease
- •Implanted electronic device
- •Joint or overlying skin infection of the affected limb
- •History of recurrent skin infections
- •Bleeding disorder
- •Allergy to skin surface electrodes and/or medical-grade adhesive tapes
研究组 & 干预措施
Peripheral Nerve Stimulation
All study subjects will have up to 2 Smartpatch Leads placed in their leg that underwent total knee replacement, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.
干预措施: SPRINT Peripheral Nerve Stimulation (PNS) System (Device)
结局指标
主要结局
Average Knee Pain While Walking
时间窗: Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))
Subjects were asked to complete daily diaries to track their average pain intensity while walking during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean scores for weeks 1-4 is reported.
Number of Participants That Experienced at Least One Study-Related Adverse Event
时间窗: Total of 21 months (from when the first subjects enrolled to when the last subject completed the study)
At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.
次要结局
- Average Knee Pain Over the Last 24 Hours(Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA)))
- Average Knee Pain at Rest(Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA)))
- Amount of Analgesic Usage(Visit 4 (Day of Surgery) and Visits 6-11 (weeks 1-6 post-Total Knee Arthroplasty (TKA)))
- Number of Participants That Experienced at Least One Opioid-Related Side Effect(Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA)))
- Time to Achieve 90 Degrees Flexion in Affected Knee(Visit 2 (Lead Placement), Visit 7 (3-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA))
- Timed Up and Go (TUG) Test(Visit 1 (Baseline), Visit 5 (In-Hospital), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA))
- 6 Minute Walk Test (6MWT)(Visit 1 (Baseline), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA))
- Fixed Distance Walk Test(Visit 1 (Baseline) and Visit 5 (In-Hospital))
- Percent Change From Baseline on the Western Ontario McMaster University Osteoarthritis Index (WOMAC)(Visit 1 (Baseline), Visit 5 (In-Hospital), Visit 7 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 11 (6-weeks Post-TKA), Visit 13 (3-months Post-TKA))
- Knee Pain Interference With Daily Activities(Visit 1 (Baseline), Visit 2 (Lead Placement), Visits 5-13 (in-hospital days through 3-months post-Total Knee Arthroplasty (TKA)))
- Number of Participants Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey(Visits 5-13 (in-hospital through 3-months post-Total Knee Arthroplasty (TKA)))
- Pain Catastrophizing Scale (PCS)(Visit 1 (Baseline), Visit 11 (6-weeks post-Total Knee Arthroplasty (TKA)), Visit 13 (3-months post-TKA))
- Time to Meet Recovery Milestones up to Three Months Post-Total Knee Arthroplasty (TKA)(From Day of Surgery through completion of milestone or 3-months from Day of Surgery, whichever came first)
- Subject Satisfaction Survey(Visit 11 (6-weeks post-Total Knee Arthroplasty (TKA)))