Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections

NCT03941327 | Unknown DMC FDA Device

• 1 other identifier: 2018-0212
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Axoguard nerve protectors have a role in preventing shoulder disability and pain following spinal accessory nerve sparing neck dissections.

Conditions

Spinal Accessory Nerve Injury; Cervical Lymphadenopathy

Outcome Measures

Primary Outcomes (1)

• Shoulder function

  Shoulder function will be assessed by Constant-Murley shoulder scale. The Constant-Murley shoulder scale is a validated subjective and objective survey of overall shoulder function. The scale ranges from 0 (no shoulder function) to 100 (perfect shoulder function). It consists of several questions about pain and disability as well as actual shoulder testing that will be performed by the consenting physician during the participant's clinic appointment.

  The comparison of improvement or change in shoulder function over 6 months between the control and intervention groups will be the primary outcome measure.

Secondary Outcomes (1)

• Postoperative pain following neck dissection: rate shoulder pain from 1-10

  Patients will be asked to rate shoulder pain from 1-10 at each postoperative visit over the course of 6 months.

Study Arms (2)

Control

PLACEBO COMPARATOR

Patients who provide consent for implant placement but do not receive the implant.

Device: AxoGuard Nerve Cuff

Interventional

EXPERIMENTAL

Patients who provide consent for implant placement and do receive the implant.

Device: AxoGuard Nerve Cuff

Interventions

AxoGuard Nerve Cuff DEVICE

A porcine collagen implant will be used to make a protective sheath around the participant's exposed spinal accessory nerve during surgery. This will be performed by physically wrapping the exposed nerve with the implant and suturing the ends together. The goal is to protect nerve from adhesions and compression in the absence of normal protective lymphatic soft tissue.

Control; Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• History of modified radical neck dissection involving removal of spinal accessory nerve or sternocleidomastoid muscle
• History of radical neck dissection
• History of pre- existing disabling shoulder complaints
• \<18 years of age
• Any individual unable to provide consent for his/her self.
• Any individual with allergy, sensitivity, or aversion to porcine material.

Sponsors & Collaborators

• University of Mississippi Medical Center: lead

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

MeSH Terms

Conditions

Accessory Nerve Injuries

Condition Hierarchy (Ancestors)

Accessory Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Cranial Nerve Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Jaxon W Jordan, M.D.

CONTACT

325-370-2063; jwjordan@umc.edu

Gina Jefferson, M.D.

CONTACT

3124339898; gjefferson@umc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be randomly assigned to a control group or intervention group using a computer based randomization tool. Patient's undergoing bilateral neck dissection will receive an implant on one side and act as self control.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 7, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

US (1)