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临床试验/NCT03818022
NCT03818022撤回不适用

Effectiveness of Preoperative Cryoneurolysis (Iovera) for Postoperative Pain Control in Total Knee Arthroplasty

Fondren Orthopedic Group L.L.P.2 个研究点 分布在 1 个国家开始时间: 2019年2月1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
2
主要终点
Knee Injury and Osteoarthritis Outcomes Survey (KOOS Jr)

研究概览

简要总结

The purpose of this study is to assess the potential benefit of preoperative cryoneurolysis in postoperative pain management of total knee arthroplasty patients over current pain management protocol.

详细描述

Cryoneurolysis, is a novel technique that can yield temporary blockade of superficial sensory nerves, generating immediate and meaningful relief of pain.The technique generates an axonotmesis of the targeted peripheral nerves by percutaneously applying low temperatures (-100 °C to -20 °C). Wallerian degeneration is produced whereby the axons and the myelin sheath are damaged but the endoneurium, perineurium and epineurium remain intact. Therefore, permanent damage to the nerve is avoided as it retains its regenerative properties. With regards to the knee, the infrapatellar branch of the saphenous nerve (IPBSN), a sensory branch serving both the inferior and anterior portion of the knee capsule and the antero-medial skin of the knee is the prime target for the procedure.

Your participation in this study requires that you allow the radiology department of Texas Orthopedic Hospital to administer Cryoneurolysis using the Iovera device with the functional smart tip approximately 1 week prior to total knee arthroplasty surgery. A highly localized cold zone is created via the Joule-Thompson effect as nitrous oxide enters the needles. Nothing is injected into the body and the nitrous oxide gas is vented safely out of the handpiece. Cryoneurolysis is administered following local anesthesia.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • any patient scheduled for primary total knee arthroplasty(TKA)

排除标准

  • Bilateral TKA (patients routinely receive spinal anesthesia)
  • Patients reporting a history of Raynaud's disease
  • Patients with an open and/or infected wound on surgical knee
  • Patients who are taking opioids during the pre-operative period due to knee pain
  • Patients who cannot return for the cryoneurolysis treatment 7 days prior to surgery or post-operative clinical visits
  • Patients whose insurance would deny payment for the cryoneurolysis treatment
  • Pregnant patients
  • Patients unable to speak and read English

结局指标

主要结局

Knee Injury and Osteoarthritis Outcomes Survey (KOOS Jr)

时间窗: up to 3 months

KOOS Jr. is a short questionnaire that evaluates knee pain and function. Scores range from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.

Veterans Rand-12 (VR-12)

时间窗: up to 3 months

VR-12 is a 12 item questionnaire that measures health related quality of life. Scores range from 0 to 100 with 50 being an average score and higher scores representing better health related quality of life.

次要结局

  • Knee swelling(up to 3 months)
  • Knee function(up to 3 months)
  • Number of subject with an adverse effect from treatment(up to 3 months)
  • Range of motion(up to 3 months)

研究者

发起方
Fondren Orthopedic Group L.L.P.
申办方类型
Other
责任方
Sponsor

研究点 (2)

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