Comparison Between Cooled (C-RFA) and Standard (t-RFA) Radiofrequency Ablation, and Control for Pain Management Following Unilateral Knee Arthroplasty: A Double-Blinded, Parallel-Grouped, Placebo-Controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Postoperative analgesic consumption
研究概览
简要总结
Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency ablation (C-RFA), is now available for knee pain management. Both t-RFA and C-RFA offer minimally invasive, non-surgical, non-opioid pain relief options following surgery. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative genicular C-RFA, t-RFA, and control placebo/sham. The aim of this study is to establish if C-RFA and t-RFA, offered preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative pain relief.
详细描述
Total knee replacements are a leading orthopedic procedure in the United States totaling 600,000 in 2010, and are anticipated to grow to 3.48 million procedures by 2030. Three primary reasons prolong hospital stays following unilateral knee arthroplasty. Pain is the primary reason followed by opioid drowsiness and nausea/vomiting side effects. Reducing opioid usage and decreasing hospital length of stays are paramount in improving patient care during recovery and rehabilitation, subsequently reducing overall costs associated with total knee replacement. Standard genicular radiofrequency ablation (t-RFA) has been effective pain management for non-operative knee pain associated with osteoarthritis. Additionally, cooled radiofrequency ablation (C-RFA), which was previously used for spinal pain, is now available for knee pain management. C-RFA, compared to t-RFA, causes large volume spherical lesions and potentially reduces time and fluoroscopic exposure with direct placement techniques. However, both t-RFA and C-RFA offer a minimally invasive, non-surgical, non-opioid pain relief options following surgery. Preliminary reports involving 40 patients who underwent either C-RFA or t-RFA prior to unilateral knee arthroplasty by the investigator indicate both procedures improved postoperative pain assessments and decreased opioid/narcotic utilization. The study will perform a double-blinded, parallel grouped, placebo-controlled randomized study to compare three pain management paradigms involving preoperative C-RFA, t-RFA, and sham. The aim of this study is to establish if C-RFA and t-RFA, offered preoperatively to patients undergoing unilateral knee arthroplasty, provide postoperative pain relief, reduce hospital length of stays and decrease opioid utilization thereby improving patient outcomes and decreasing overall costs.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Osteoarthritis of the knee where unilateral knee arthroplasty is indicated by radiograph, function decrease and/or pain indication and readiness to undergo t-RFA, C-RFA or sham treatment.
排除标准
- •□ • NO DAILY OPIOID CONSUMPTION 5 WEEKS PRIOR TO ENROLLMENT
- •NO DOCUMENTED NARCOTIC DEPENDENCY OR RECREATIONAL DRUG USE
- •NO TOBACCO USAGE WITHIN 2 MONTHS PRIOR TO SURGERY
- •NO CONFOUNDING INFLAMMATORY ARTHRITIS DISEASES ARE PRESENT
- •NO NEUROPATHY OR NEURO IMPAIRMENT PRESENT
- •NO SIGNIFICANT ACUTE ILLNESS OR INFECTION
- •NO OTHER CONFOUNDING CHRONIC PAIN
- •NO INVESTIGATIONAL AGENT WITHIN 3 MONTHS PRIOR TO ENROLLMENT
- •NO DIAGNOSED THROMBOPHILIA
- •NO SEVERE CARDIAC OR PULMONARY COMPROMISE
- •NO BLEEDING DISORDER(S)
- •NO ALLERGIC REACTION TO LOCAL ANESTHESIA, STEROIDS, OR IMPLANT MATERIALS
- •NO BREASTFEEDING
- •NO PREGNANCY
- •NO CONFOUNDING PSYCHIATRIC ILLNESSES
- •NO CONFOUNDING MAJOR TRAUMA HARDWARE REMOVALS OR PRIOR TKA *NO CONTRAINDICATED BODY HABITUS TO BE DETERMINED BY A TREATMENT PROVIDER
研究组 & 干预措施
Standard Thermal radiofrequency ablation
Patients randomized to t-RFA will receive standard genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty for postoperative pain management.
干预措施: t-RFA (Procedure)
Cooled radiofrequency ablation
Patients randomized to C-RFA will receive cooled genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty for postoperative pain management.
干预措施: C-RFA (Procedure)
Control:Placebo Sham
Patients randomized to control will receive simulated genicular thermal radiofrequency ablation at least 3 weeks prior to unilateral knee arthroplasty and receive the industry standard of care for unilateral knee arthroplasty pain management.
干预措施: Control (Procedure)
结局指标
主要结局
Postoperative analgesic consumption
时间窗: 0 - 3 weeks postoperatively
Measure opioid consumption for the three study arms
Hospital Length of Stay (LOS)
时间窗: 0-5 days postoperatively
Measure hospital length of stay for the three study arms
次要结局
- Pain Score(before treatment arm procedures to 12 months after unilateral knee arthroplasty)