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Cryoneurolysis in Anterior Cruciate Ligament Reconstruction (ACLR)

2026年7月23日 更新者：NYU Langone Health

Evaluating the Efficacy of Preoperative Cryoneurolysis With Iovera on Postoperative Pain, Function, and Opioid Use Following ACL Reconstruction With Bone-Patellar Tendon-Bone Autograft

The purpose of this research study is to assess whether cryoneurolysis will help control pain after ACLR surgery and decrease the need of opioid medications. The primary objective is to compare postoperative functional recovery between Iovera and sham arms at 1 month after ACLR.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • New York
      • New York、New York、美国、10016
        • NYU Langone Health

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age 18-45 years
  2. Scheduled for primary ACLR with BPTB autograft
  3. Willingness and ability to participate in Iovera
  4. No chronic opioid use preoperatively
  5. No known neurologic disorders affecting the lower extremity
  6. Capacity and willingness to provide informed consent and comply with follow-up schedules

Exclusion Criteria:

  1. Prior surgery on the affected knee.
  2. Non-English speaking if validated PRO instruments at the site are only available in English; include validated translations if available and approved.
  3. Contraindications to cryoneurolysis (e.g., cryoglobulinemia, cold urticaria, Raynaud's phenomenon, paroxysmal cold hemoglobinuria) or to local anesthetics.
  4. Active skin infection, dermatitis, or compromised skin integrity at or near treatment sites.
  5. Bleeding diathesis or anticoagulant therapy not compatible with minor percutaneous procedures per institutional policy.
  6. Pregnancy or breastfeeding.
  7. Known peripheral neuropathy or significant sensory deficit of the target region.
  8. Any condition that, in the investigator's judgment, increases risk or interferes with participation
  9. Concomitant use of other opioid drugs or prior chronic use.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Ioveraº cryoneurolysis study group
Participants will receive the ioveraº cryoneurolysis intervention before surgery.
设备：Pacira Iovera Cryoneurolysis device
The device includes a hand-held piece, charging port with cord, and disposable components: the nitrous oxide capsule and a small probe called the Smart Tip, which has needles that administer the cold to the nerve. It works immediately by freezing nerves that transmit pain signals to reduce pain transmission after surgery.
假比较器：Placebo study group
Participants will have a sham intervention that does not have cryoneurolysis before surgery.
设备：Placebo/Sham device
The placebo/sham device looks just like the ioveraº device, but does not contain cyoneurolysis or any treatment.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Difference in Knee Injury and Osteoarthritis Outcome Score (KOOS)
大体时间：Baseline, 1 Month
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Baseline, 1 Month
Difference in Lysholm knee scoring scale (LKSS)
大体时间：Baseline, 1 Month
The Lysholm knee scoring scale is a 100-point patient-reported questionnaire designed to assess functional knee ligament injuries. It evaluates eight areas - limp, support, locking, instability, pain, swelling, stair climbing, and squatting - with higher scores (up to 100) indicating better function.
Baseline, 1 Month

次要结果测量

结果测量
措施说明
大体时间
Change in Visual Analogue Scale (VAS) for Pain score
大体时间：Baseline, Post-operative Day 1
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Baseline, Post-operative Day 1
Change in Visual Analogue Scale (VAS) for Pain score
大体时间：Baseline, Week 3
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Baseline, Week 3
Change in Visual Analogue Scale (VAS) for Pain score
大体时间：Baseline, Month 6
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Baseline, Month 6
Change in Numeric Rating Scale (NRS)
大体时间：Baseline, Post-operative Day 1
A segmented, numbered version of the VAS. Patients select a whole number from 0 to 10 where 0 is "no pain" and 10 is the "worst pain imaginable"
Baseline, Post-operative Day 1
Change in Numeric Rating Scale (NRS)
大体时间：Baseline, Week 3
A segmented, numbered version of the VAS. Patients select a whole number from 0 to 10 where 0 is "no pain" and 10 is the "worst pain imaginable"
Baseline, Week 3
Change in Numeric Rating Scale (NRS)
大体时间：Baseline, Month 6
A segmented, numbered version of the VAS. Patients select a whole number from 0 to 10 where 0 is "no pain" and 10 is the "worst pain imaginable"
Baseline, Month 6
Cumulative opioid consumption as measured by morphine milligram equivalents (MME)
大体时间：Up to 21 days post-operative
Up to 21 days post-operative

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

NYU Langone Health

调查人员

  • 首席研究员：Eric J. Strauss, MD、NYU Langone Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2028年8月1日

研究注册日期

首次提交

2026年7月23日

首先提交符合 QC 标准的

2026年7月23日

首次发布 (实际的)

2026年7月28日

研究记录更新

最后更新发布 (实际的)

2026年7月28日

上次提交的符合 QC 标准的更新

2026年7月23日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 25-00771

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

This is a single-site device study. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to layne.estes@nyulangone.org.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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