Clinical trial NCT03941327: Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections
Official title: Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Accessory Nerve Injury
Cervical Lymphadenopathy
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Shoulder function
timeFrame: 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:
measure: Postoperative pain following neck dissection: rate shoulder pain from 1-10
timeFrame: Patients will be asked to rate shoulder pain from 1-10 at each postoperative visit over the course of 6 months.
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
References: