Axoguard HA Plus Nerve Protector to Reduce Post-operative Neck and Shoulder Dysfunction in Patients Undergoing Neck Dissection

Matthew Spector

Status: Enrolling

Conditions: Neck Dissection; Head and Neck Cancer

Treatments: Device: Spinal Accessory Nerve Protection utilizing Axoguard HA+

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07283861

STUDY25060040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

90 participants in 1 patient group

Axoguard HA+ Arm

Experimental group

Treatment:

Device: Spinal Accessory Nerve Protection utilizing Axoguard HA+