A Phase 2 Trial of Accessory Nerve Wrapping With the Axoguard HA Plus Nerve Protector to Reduce Post-operative Neck and Shoulder Dysfunction in Patients Undergoing Neck Dissection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- One year neck and shoulder dysfunction as assessed by the neck dissection impairment index
研究概览
简要总结
In this prospective study, patients with head and neck cancers undergoing neck dissection will have the nerve to the shoulder wrapped with the Axoguard HA+ Nerve Protector at time of surgery. In these patients, the presence and severity of neck and shoulder dysfunction on the operated side will be assessed approximately twelve months post-operatively. The investigators hypothesize that shoulder nerve wrapping with the Axoguard HA+ Nerve Protector will lead to clinically meaningful improvement of shoulder function.
详细描述
All patients will undergo neck dissection and the spinal accessory nerve wrapped with the Axoguard HA+ Nerve Protector. The Neck Dissection Impairment Index will be administered before surgery and 1 year after surgery and compared to historical controls. The NDII is on a 100 point scale with a higher score indicating a better shoulder function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously untreated malignancy of the head and neck including primary mucosal, cutaneous, salivary gland, and thyroid cancers
- •Undergoing accessory-nerve sparing elective or therapeutic SND or MRND (involving level II and/or level V dissection)
- •18 years or older
- •Patients must give documented informed consent to participate in this study
排除标准
- •Previous history of neck or shoulder surgery or radiation
- •Inadvertent injury to or intentional sacrifice of the accessory nerve at time of neck dissection
- •Medical contraindication to surgery under general anesthesia
- •Known sensitivity to porcine materials
- •Pregnant or lactating patients
- •Incarcerated patients
研究组 & 干预措施
Axoguard HA+ Arm
干预措施: Spinal Accessory Nerve Protection utilizing Axoguard HA+ (Device)
结局指标
主要结局
One year neck and shoulder dysfunction as assessed by the neck dissection impairment index
时间窗: one year
The neck dissection impairment index is a score from 1-100 with 100 being a perfect score.
One year neck and shoulder dysfunction as assessed by the neck dissection impairment index
时间窗: one year
The neck dissection impairment index is a score from 1-100 with 100 being a perfect score.
次要结局
未报告次要终点
研究者
Matthew Spector
Professor
University of Pittsburgh