Impact of Porcine Extracellular Matrix Nerve Wrap on Spinal Accessory Nerve in Patients Undergoing Neck Dissection for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change from baseline in shoulder flexion active range of motion (degrees)
研究概览
简要总结
Perform a preliminary efficacy study using the porcine extracellular matrix nerve wrap (AxoGuard Nerve Protector™, AxoGen Inc., Alachua, FL) to wrap the spinal accessory nerve (SAN) during neck dissections for head and neck cancer as it relates to postoperative shoulder function, both subjectively and objectively.
详细描述
Many patients who have surgery for head and neck cancer also need a procedure called a neck dissection, where lymph nodes and tissue are removed from the neck. During this surgery, even when a nerve called the spinal accessory nerve (SAN) is carefully preserved, patients often have shoulder problems afterward. These problems can include pain, weakness, and difficulty lifting the arm, which can affect daily activities and quality of life.
This study is testing whether using a special nerve wrap made from pig tissue (called AxoGuard® Nerve Protector) can help protect the spinal accessory nerve during surgery and improve shoulder movement and strength after surgery. This nerve wrap is already used in other types of nerve surgeries and may help the nerve heal better by reducing scar tissue and irritation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patients at least 18 years old
- •Patients with no previous treatment of head and neck cancer
- •Patients with no prior neck surgeries
- •Patients undergoing level IIA and IIB neck diss
排除标准
- •Patients with previously treated head and neck cancers
- •Patients undergoing level V neck dissection
- •Patients undergoing bilateral neck dissection
- •Patients with previous neck surgery unrelated to head and neck cancer
- •Patients allergic to porcine products or with religious/cultural restrictions on porcine products
- •Patients unable to consent
- •Individuals who are not adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Treatment Arm - Neck dissection with AxoGuard Nerve Protector™
Participants undergo neck dissection surgery for head and neck cancer, during which the spinal accessory nerve (SAN) is wrapped with the AxoGuard Nerve Protector™ (porcine extracellular matrix nerve wrap). This intervention aims to improve postoperative shoulder function by protecting and supporting the nerve during healing. Postoperative physical therapy evaluations will be conducted at baseline, immediate post-op, 1, 6, and 12 months.
干预措施: Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™) (Device)
Control Arm - Neck dissection without AxoGuard Nerve Protector™.
Participants undergo standard neck dissection surgery for head and neck cancer without the application of the AxoGuard Nerve Protector™. Postoperative physical therapy evaluations will be conducted at baseline, immediate post-op, 1, 6, and 12 months to assess shoulder function.
结局指标
主要结局
Change from baseline in shoulder flexion active range of motion (degrees)
时间窗: From preoperative baseline assessment up to 12 months post-surgery
Shoulder flexion active range of motion will be measured using goniometry. A clinically significant decline is defined as a ≥12° decrease compared to preoperative baseline. Unit of Measure: Degrees
Change from baseline in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score
时间窗: From preoperative baseline assessment up to 12 months post-surgery
Subjective upper extremity function will be assessed using the QuickDASH questionnaire (0-100 scale, higher scores indicate worse disability). Unit of Measure: Score
Change from baseline in Neck Dissection Impairment Index (NDII) score
时间窗: From preoperative baseline assessment up to 12 months post-surgery
Subjective shoulder-related quality of life will be assessed using the NDII questionnaire (0-50 scale, higher scores indicate greater impairment). Unit of Measure: Score
Change from baseline in shoulder abduction active range of motion (degrees
时间窗: From preoperative baseline assessment up to 12 months post-surgery
Shoulder abduction active range of motion will be measured using goniometry. A clinically significant decline is defined as a ≥23° decrease compared to preoperative baseline. Unit of Measure: Degrees
次要结局
未报告次要终点
研究者
Samantha Tam
Vice Chair-Otolaryngology • Otolaryngology
Henry Ford Health System