Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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