A Prospective, Multi-Center, RCT Evaluating the Safety and Effectiveness of Coolief™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing Corticosteroid Injection in the Management of Knee Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 11
- 主要终点
- Numeric Rating Scale (NRS)
研究概览
简要总结
This study is designed to:
- Determine the effectiveness (primarily measured by pain relief) of Coolief when used to create radiofrequency lesions of the genicular nerves compared to pain relief following corticosteroid injection; and
- Confirm the safety of Coolief when used to perform radiofrequency lesions of the genicular nerves in subjects to manage knee pain compared to safety of corticosteroid injection
详细描述
This is a prospective, randomized, multicenter comparison study examining the outcomes of subjects having knee pain undergoing a procedure to create a radiofrequency lesion of the genicular nerves with the Coolief system compared to subjects receiving corticosteroid injection. A total of approximately 144 subjects will be enrolled into this study with subjects undergoing either radiofrequency neurotomy or corticosteroid injection in a 1:1 randomization scheme. Follow up will be conducted for a total of 12 months post Coolief procedure with the primary endpoint being completed at month 6. Subjects randomized to the comparison (corticosteroid) group will have the option to cross over to the neurotomy group after completing the 6 month endpoint assessment. They would then be followed for an additional 6 months. Pain, overall outcome, quality of life, pain medication use, and adverse events will be compared between the two treatment groups in order to determine success.
Primary Effectiveness Endpoint:
The proportion of subjects whose knee pain is reduced by ≥ 50% based on the NRS scale at 6 Months.
Primary Safety Endpoint:
The proportion of subjects experiencing adverse events through final follow up.
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
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cooled radiofrequency
Cooled radiofrequency energy will be delivered to study subjects' knees to ablate culprit sensory nerves and reduce knee pain
干预措施: Cooled Radiofrequency (Device)
Corticosteroid injection
Corticosteroid injections will be administered to study subjects' knees to reduce knee pain
干预措施: Corticosteroid injection (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS)
时间窗: 6 months
The number of subjects whose knee pain is reduced by ≥ 50% based on the Numeric Rating Scale (NRS). The NRS is an 11-point scale (0 points to 10 points), where 0 points equals "no pain" and 10 points equals the "worst pain".
Safety: Number of Subjects Experiencing Adverse Events Through Final Follow up.
时间窗: 6 months and 12 months
Safety Endpoint: Number of subjects experiencing adverse events through final follow up.
次要结局
- Numeric Rating Scale(12 months)
- Oxford Knee Score(6 months and 12 months)