Recruiting

AxoGuard Implants

Sponsor:

University of Mississippi Medical Center

Code:

NCT03941327

Conditions

Spinal Accessory Nerve Injury

Cervical Lymphadenopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AxoGuard Nerve Cuff

Study Details

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

Study ID

NCT03941327

Start date

May 1, 2019

Status verified date

May, 2019

Completion date

May 1, 2020

Anticipated

Primary completion date

May 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

-Any neck dissection (cervical lymphadenectomy) that involves resection of level 2 cervical lymph nodes for malignancy and does not fall into the categories listed under the exclusion criteria.

Exclusion Criteria:

1. History of modified radical neck dissection involving removal of spinal accessory nerve or sternocleidomastoid muscle
2. History of radical neck dissection
3. History of pre- existing disabling shoulder complaints
4. <18 years of age
5. Any individual unable to provide consent for his/her self.
6. Any individual with allergy, sensitivity, or aversion to porcine material.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Control

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

experimental: Interventional

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

Interventions

AxoGuard Nerve Cuff

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.

Primary outcome measure

  • Shoulder function [ Time Frame: The comparison of improvement or change in shoulder function over 6 months between the control and intervention groups will be the primary outcome measure. ]

Central Contacts and Locations

Central contacts

Jaxon W Jordan, M.D.

325-370-2063jwjordan@umc.edu

Gina Jefferson, M.D.

3124339898gjefferson@umc.edu

Locations

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Gina Jefferson

312-433-9898gjefferson@umc.edu

More Information

Sponsor

University of Mississippi Medical Center

Last update posted

May 7, 2019

Last verified

May, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Mississippi Medical Center on 2019-05-07.