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临床试验/NCT05130216
NCT05130216已完成不适用

A Single-arm Pilot Study of Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty

University of Utah1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年9月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Numeric ranking scale (NRS) pain

研究概览

简要总结

Determine if genicular nerve radiofrequency ablation (RFA) is a clinically effective intervention for patients with chronic knee pain post-total knee arthroplasty (TKA) as defined by pain.

详细描述

More than 600,000 total knee arthroplasty (TKA) surgeries are performed each year in the United States, and approximately 20% of patients will experience some element of chronic knee pain or dissatisfaction related to pain following this procedure. The options for management are limited, and physicians often resort to chronic opioid management. This creates a less than ideal situation for our elderly population who are more sensitive to the deleterious effects of opioids and who would greatly benefit from pain-free, independent mobility. The investigators propose a single-arm pilot study looking at performing fluoroscopically guided genicular nerve radiofrequency ablation (RFA) for patients with chronic (>6 months) knee pain following a TKA.

A new paradigm for treating post-TKA pain may be the use of RFA of the articular sensory nerve supply of the knee capsule, to desensitize the knee by blocking sensory afferents of the anterior capsule and thereby decreasing pain. While this modality has demonstrated efficacy for chronic knee pain due to osteoarthritis (OA) in the native knee, only one underpowered study has investigated this technique in chronic pain post-TKA. Further, this study targeted only three genicular nerves, while newer cadaveric studies have suggested multiple additional sensory nerves which if ablated may result in increased pain relief. A placebo-controlled explanatory trial of genicular nerve RFA for chronic pain post-TKA of appropriate size and statistical methodology has not been conducted.

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
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 30 to 90 years
  • At least one year post TKA
  • Have no indications for revision TKA
  • ≥4/10 knee pain for >6 months following TKA
  • ≥80% relief with diagnostic genicular nerve blocks
  • Willingness to undergo fluoroscopy-guided genicular nerve RFA treatment.

排除标准

  • Conditions that preclude RFA (e.g. pregnancy, pacemaker/ICD, severe cardiac/pulmonary compromise; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic.
  • Inability to write, speak or read in English
  • Patient refusal
  • Significant psychiatric comorbidity

研究组 & 干预措施

Total Knee Arthroplasty

Patients who have undergone total knee arthroplasty post one-year.

干预措施: Genicular Nerve Radiofrequency Ablation (Other)

结局指标

主要结局

Numeric ranking scale (NRS) pain

时间窗: 6-months post-genicular nerve RFA

NRS pain score (0 no pain - 10 severe pain)

Numeric ranking scale (NRS) pain

时间窗: Prior to nerve radiofrequency ablation (RFA)

NRS pain score (0 no pain - 10 severe pain)

Numeric ranking scale (NRS) pain

时间窗: 1-month post-genicular nerve RFA

NRS pain score (0 no pain - 10 severe pain)

Numeric ranking scale (NRS) pain

时间窗: 3-months post-genicular nerve RFA

NRS pain score (0 no pain - 10 severe pain)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lucas Anderson

Principle Investigator

University of Utah

研究点 (1)

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