Total Knee Arthroplasty in Conjunction With Intra-operative Genicular Nerve Radio-Frequency Ablation, A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Post operative pain
研究概览
简要总结
The aim of this study is to compare between conventional Total Knee Arthroplasty (TKA) and Total Knee Arthroplasty (TKA) combined with intra-operative Genicular Nerve Radio-Frequency Ablation (GNRFA), concerning post-operative functional outcome and pain scores in patients with advanced knee osteoarthritis
详细描述
The aim of this study is to compare between conventional Total Knee Arthroplasty (TKA) and Total Knee Arthroplasty (TKA) combined with intra-operative Genicular Nerve Radio-Frequency Ablation (GNRFA), concerning post-operative functional outcome and pain scores in patients with advanced knee osteoarthritis
Including 70 knees randomized using a computer-generated sequence into two groups, the first group underwent TKA combined with GNRFA, and the other group underwent TKA only. All the TKA surgeries were performed by a single surgeon including patients aged from fifty to eighty years with advanced primary knee osteoarthritis from both sexes
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced knee osteoarthritis
- •Both sexes
- •Age from 50-80 years old
排除标准
- •Patients underwent previous GNRFA
- •Patients underwent previous knee surgery
- •patients requiring constrained knee arthroplasty prosthesis (with extreme deformities)
研究组 & 干预措施
Control
underwent Total knee arthroplasty only
干预措施: Total knee arthroplasty (Procedure)
Genicular nerve radio-frequency ablation
underwent Total knee arthroplasty with genicular nerve radio-frequency ablation
干预措施: Total knee arthroplasty (Procedure)
Genicular nerve radio-frequency ablation
underwent Total knee arthroplasty with genicular nerve radio-frequency ablation
干预措施: Genicular nerve radiofrequency ablation (Procedure)
结局指标
主要结局
Post operative pain
时间窗: 6 months post operative
pain assessment using Visual analogue scale, minimum value is 0 meaning no pain and maximum value is 10 meaning the worst pain, higher score means worse outcome
Post operative knee functional outcome
时间窗: 6 months
measuring the knee functional outcome post operative using oxford knee score, minimum score is 0 meaning the worse outcome and maximum is 48 meaning the best outcome. higher score means better outcome
次要结局
未报告次要终点