Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections

NCT ID: NCT03941327

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-05-01

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.

Detailed Description

The spinal accessory nerve is often manipulated during selective neck dissections in order to remove the fibrofatty tissues containing lymph nodes surrounding the nerve. Afterwards the nerve is left exposed without it's normal support making it vulnerable to adhesions, compression, and stretch injury. Axoguard nerve wraps have shown significant promise in preventing the recurrence of carpal tunnel following forearm surgery, and preventing impotence and incontinence following nerve sparing robotic radical prostatectomy. The investigators hypothesize that the same technology may aid in reducing shoulder disability and pain if used in spinal accessory nerve sparing neck dissections. In this prospective single blinded randomized controlled study the investigators will randomly assign patients to a control group that will not receive the AxoGuard nerve wrap, and a study group that will receive the AxoGuard nerve wrap around their exposed spinal accessory nerve(s) using a research randomization tool. The results will be stratified into groups including preoperative and postoperative stage of disease, preoperative and postoperative nodal (neck) stage, history of radiation, and whether or not level 2B was dissected. Individuals with a history of pre-existing disabling shoulder complaints, individuals under the age of 18, individuals who cannot provide their own informed consent, and individuals undergoing a neck dissection that will remove the sternocleidomastoid muscle or spinal accessory nerve will be excluded from the study. Patients will undergo preoperative shoulder assessment using the Constant-Murley shoulder outcome score at their initial clinical visit. Postoperative outcomes will be recorded at 2 weeks, 2 months, 4 months, and 6 months and measured by the Shoulder Disability Questionnaire, Rand-36 quality of life survey, pain scale, and Constant-Murley shoulder outcome score. With this study the investigators aim to show a clinically significant improvement in shoulder function following spinal accessory nerve sparing neck dissections when AxoGuard nerve wraps are used to protect the nerve. Additionally, the investigators aim to improve patient satisfaction, decrease post-op pain, and improve quality of life.

Conditions

Spinal Accessory Nerve Injury; Cervical Lymphadenopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

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

Group Type: PLACEBO_COMPARATOR

AxoGuard Nerve Cuff

Intervention Type: 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.

Interventional

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

Group Type: EXPERIMENTAL

AxoGuard Nerve Cuff

Intervention Type: 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.

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Mississippi Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jaxon W Jordan, M.D.

Role: CONTACT

jwjordan@umc.edu

325-370-2063

Gina Jefferson, M.D.

Role: CONTACT

gjefferson@umc.edu

3124339898

Facility Contacts

Gina Jefferson

Role: primary

gjefferson@umc.edu

312-433-9898

Other Identifiers

2018-0212

Identifier Type: -

Identifier Source: org_study_id