NCT03647332Unknown不适用
Use of Cooled Radiofrequency for the Treatment of Hip Pain Associated With OA of the Hip Compared to Intra-articular Steroid Injections
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
This will be a single-center, prospective, single-blinded randomized clinical trial to investigate the effectiveness of using cooled RFA for the treatment of OA hip pain and function in subjects treated with cooled RFA compared with standard of care intra-articular steroid injections
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects presenting with radiographic evidence of hip OA and demonstrating hip pain for at least 30 days will be targeted. Radiographic evidence of hip OA is defined as Kellegran-Lawrence grade 2-4
- •Not an operative candidate as per RI joint replacement surgeon OR
- •Subjects who do not desire joint replacement surgery after consultation with RI joint replacement surgeon
- •Male or non-pregnant female older than 18 years of age
- •willing and able to sign the IRB-approved informed consent document.
排除标准
- •Any steroid injection in hip within 90 days
- •Local infection at injection site or active systemic infection
- •Anticoagulation status with inability to discontinue medication for appropriate duration for nerve blocks and RFA given proximity to major artery. (No anticoagulation contraindications for joint injection)
- •AICD with inability to utilize magnet for RFA per treating cardiologist
- •Body habitus does not allow for placement of longest needles and electrodes (approximately 15cm) to successfully administer treatment
- •Allergy or severe renal impairment precluding iodionated contrast or magnavist injection despite standard premedication protocol
研究组 & 干预措施
Cooled RFA treatment
Active Comparator
干预措施: Cooled RFA treatment (Procedure)
Steroid injection
Active Comparator
干预措施: Steroid Drug (Drug)
结局指标
主要结局
Pain
时间窗: 24 weeks following treatment
Visual Analog Scale
次要结局
未报告次要终点
研究者
研究点 (1)
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