Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Axogen Corporation | INDUSTRY |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axoguard HA+ Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Accessory Nerve Protection utilizing Axoguard HA+ | Device | Nerve protection utilizing a nerve wrap. |
|
| Measure | Description | Time Frame |
|---|---|---|
| One year neck and shoulder dysfunction as assessed by the neck dissection impairment index | The neck dissection impairment index is a score from 1-100 with 100 being a perfect score. | one year |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel Zandberg | University of Pittsburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Shadyside | Pittsburgh | Pennsylvania | 15213 | United States |
Available upon request
12-1-25 to completion of study
Available upon request
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided