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临床试验/NCT03893292
NCT03893292撤回不适用

A Pilot Study on the Utility of Cooled Radiofrequency Ablation in Patients Prior to Total Knee Arthroplasty

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家开始时间: 2019年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Pain

研究概览

简要总结

Total knee replacement surgery is commonly performed for patients suffering from severe knee osteoarthritis. However, 20% of patients continue to experience pain after surgery. There is currently no standardized pain management protocol for pain after total knee replacement. Cooled radiofrequency ablation has been used successfully to alleviate spin-related pain and has recently been approved by the FDA to treat chronic knee arthritic pain. This pilot study aims to collect preliminary data on the use of cooled radiofrequency ablation in patients undergoing total knee replacement.

详细描述

The number of patients who undergo total knee replacement is rising significantly. However, many of these patients are dissatisfied with the results, because they continue to experience pain postoperatively. This pain can be debilitating and can also be associated with decreased quality of life. Given the increasing number of patients undergoing total knee replacement and a dissatisfaction rate of 8-44%, improvements must be made in pain management protocols to help decrease pain in the immediate postoperative period following total knee replacement. Cooled radiofrequency ablation is a procedure that uses water-cooled technology to denervate the sensory nerves. It is widely used in the spine and is increasingly being used in the knee to treat osteoarthritis. Existing studies have shown that it can significantly reduce pain in patients with chronic osteoarthritis. In terms of its potential benefit as a preoperative measure to minimize postoperative pain, the literature is sparse. Results from this study will be used to generate hypotheses and power for future studies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing unilateral primary total knee replacement for osteoarthritis
  • Pain >6 (on a scale of 0-10)
  • Body mass index: 21-35 kg/m2

排除标准

  • Age <65 years
  • Patients who are wheelchair bound
  • History of inflammatory arthritis or rheumatic disease
  • Body mass index <21 or >35 kg/m2
  • Chronic opioid use
  • Pregnant women
  • Non-English speaking

结局指标

主要结局

Pain

时间窗: Up to 1 year post-total knee replacement

Pain will be assessing on a 0-10 scale, where 0=no pain and 10=most pain.

次要结局

  • Knee Disability(Up to 1 year post-total knee replacement)
  • Function assessed using the PROMIS-physical function computer adaptive test(Up to 1 year post-total knee replacement)

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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