A Prospective, Randomized, Controlled Superiority Study to Evaluate Use of the PEAK PlasmaBlade 4.0 in Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Post-operative Pain
研究概览
简要总结
The objective of this clinical study is to evaluate the operative performance of the PEAK PlasmaBlade 4.0 during total knee replacement; to monitor and record post-operative pain, activity level, narcotic consumption, adverse events, and skin scarring following surgery; and compare these outcomes to the current standard of care (SOC).
详细描述
Total knee replacement is a surgical procedure performed to replace the weight-bearing surfaces of the knee joint. The goal of total knee replacement is to improve a patient's mobility by improving the function of the the knee joint.
The PEAK PlasmaBlade® uses pulsed radiofrequency (RF) energy and a highly-insulated handpiece design to enable precision cutting and coagulation at the point of application. The PlasmaBlade has received FDA clearance for use in plastic, general, orthopedic, and ear, nose, and throat (ENT) surgery, and has demonstrated a significantly reduced thermal injury profile in incised tissue compared to traditional electrosurgical devices. It is hypothesized that this benefit may improve the post-operative outcome of patients undergoing total knee replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 21 and 80 years old
- •Physically healthy, stable weight
- •Requiring unilateral total knee arthroplasty (TKA)
- •Subject exhibits preoperative radiographic evidence of joint degeneration consistent with TKA that cannot be treated in non-operative fashion
- •Subject has severe knee pain and disability due to degenerative joint disease
- •Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.
- •Subject must be willing and able to comply with all follow-up evaluations
- •Subject must be willing to undergo TKA using the Signature Knee System
排除标准
- •Age younger than 21 or greater than 80 years old
- •Previous history of infection in the affected joint
- •Peripheral vascular disease
- •Revision procedures
- •Valgus or varus deformity > 15 degrees
- •Flexion contracture > 15 degrees
- •History of diabetes
- •Anticoagulation therapy which cannot be discontinued
- •Cognitive impairment or mental illness
- •Severe cardiopulmonary deficiencies
- •Known coagulopathy
- •Immunocompromised
- •Kidney disease (any type)
- •Unable to follow instructions or complete follow-up
- •Currently taking any medication known to affect healing
- •Currently enrolled in another investigational device or drug trial
结局指标
主要结局
Post-operative Pain
时间窗: Postoperative (0 to 10 days)
Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.
次要结局
- Operative Metrics: Operative Time, Estimated Blood Loss, Skin Scarring, Knee Society Score (KSS)(Intraoperatively and 1-2 weeks postoperatively)