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临床试验/NCT03941327
NCT03941327Unknown不适用

Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections

University of Mississippi Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Shoulder function

研究概览

简要总结

The purpose of this study is to determine whether Axoguard nerve protectors have a role in preventing shoulder disability and pain following spinal accessory nerve sparing neck dissections.

详细描述

The spinal accessory nerve is often manipulated during selective neck dissections in order to remove the fibrofatty tissues containing lymph nodes surrounding the nerve. Afterwards the nerve is left exposed without it's normal support making it vulnerable to adhesions, compression, and stretch injury. Axoguard nerve wraps have shown significant promise in preventing the recurrence of carpal tunnel following forearm surgery, and preventing impotence and incontinence following nerve sparing robotic radical prostatectomy. The investigators hypothesize that the same technology may aid in reducing shoulder disability and pain if used in spinal accessory nerve sparing neck dissections. In this prospective single blinded randomized controlled study the investigators will randomly assign patients to a control group that will not receive the AxoGuard nerve wrap, and a study group that will receive the AxoGuard nerve wrap around their exposed spinal accessory nerve(s) using a research randomization tool. The results will be stratified into groups including preoperative and postoperative stage of disease, preoperative and postoperative nodal (neck) stage, history of radiation, and whether or not level 2B was dissected. Individuals with a history of pre-existing disabling shoulder complaints, individuals under the age of 18, individuals who cannot provide their own informed consent, and individuals undergoing a neck dissection that will remove the sternocleidomastoid muscle or spinal accessory nerve will be excluded from the study. Patients will undergo preoperative shoulder assessment using the Constant-Murley shoulder outcome score at their initial clinical visit. Postoperative outcomes will be recorded at 2 weeks, 2 months, 4 months, and 6 months and measured by the Shoulder Disability Questionnaire, Rand-36 quality of life survey, pain scale, and Constant-Murley shoulder outcome score. With this study the investigators aim to show a clinically significant improvement in shoulder function following spinal accessory nerve sparing neck dissections when AxoGuard nerve wraps are used to protect the nerve. Additionally, the investigators aim to improve patient satisfaction, decrease post-op pain, and improve quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Patients will be randomly assigned to a control group or intervention group using a computer based randomization tool. Patient's undergoing bilateral neck dissection will receive an implant on one side and act as self control.

入排标准

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

入选标准

  • Any neck dissection (cervical lymphadenectomy) that involves resection of level 2 cervical lymph nodes for malignancy and does not fall into the categories listed under the exclusion criteria.

排除标准

  • History of modified radical neck dissection involving removal of spinal accessory nerve or sternocleidomastoid muscle
  • History of radical neck dissection
  • History of pre- existing disabling shoulder complaints
  • <18 years of age
  • Any individual unable to provide consent for his/her self.
  • Any individual with allergy, sensitivity, or aversion to porcine material.

研究组 & 干预措施

Control

Placebo Comparator

Patients who provide consent for implant placement but do not receive the implant.

干预措施: AxoGuard Nerve Cuff (Device)

Interventional

Experimental

Patients who provide consent for implant placement and do receive the implant.

干预措施: AxoGuard Nerve Cuff (Device)

结局指标

主要结局

Shoulder function

时间窗: The comparison of improvement or change in shoulder function over 6 months between the control and intervention groups will be the primary outcome measure.

Shoulder function will be assessed by Constant-Murley shoulder scale. The Constant-Murley shoulder scale is a validated subjective and objective survey of overall shoulder function. The scale ranges from 0 (no shoulder function) to 100 (perfect shoulder function). It consists of several questions about pain and disability as well as actual shoulder testing that will be performed by the consenting physician during the participant's clinic appointment.

次要结局

  • Postoperative pain following neck dissection: rate shoulder pain from 1-10(Patients will be asked to rate shoulder pain from 1-10 at each postoperative visit over the course of 6 months.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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