Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections

University of Mississippi

Status: Unknown

Conditions: Spinal Accessory Nerve Injury; Cervical Lymphadenopathy

Treatments: Device: AxoGuard Nerve Cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT03941327

2018-0212

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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

Treatment:

Device: AxoGuard Nerve Cuff

Interventional

Experimental group

Description:

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

Treatment:

Device: AxoGuard Nerve Cuff