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Active, Not Recruiting

NCT Number: NCT07283861

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neck Dissection Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal Accessory Nerve Protection utilizing Axoguard HA+

Device

Nerve protection utilizing a nerve wrap.

Primary outcomes

  1. One year neck and shoulder dysfunction as assessed by the neck dissection impairment index

    Time frame: one year

    The neck dissection impairment index is a score from 1-100 with 100 being a perfect score.

Sponsors and collaborators

Lead sponsor

Matthew Spector

Other

Collaborators

  • Axogen Corporation

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 16, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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