Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections

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.

Study Overview

• Status: Unknown
• Conditions: Spinal Accessory Nerve Injury; Cervical Lymphadenopathy
• Intervention / Treatment: Device: AxoGuard Nerve Cuff

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaxon W Jordan, M.D.; Phone Number: 325-370-2063; Email: jwjordan@umc.edu
• Study Contact Backup: Name: Gina Jefferson, M.D.; Phone Number: 3124339898; Email: gjefferson@umc.edu

Study Locations

• United States
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • University of Mississippi Medical Center
      • Contact: Gina Jefferson; Phone Number: 312-433-9898; Email: gjefferson@umc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; Patients who provide consent for implant placement but do not receive the implant.	Device: 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.
Experimental: Interventional; Patients who provide consent for implant placement and do receive the implant.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain following neck dissection: rate shoulder pain from 1-10	The comparison of the improvement or change in pain scores over 6 months between the control group and intervention group will be assessed at each clinical visit over the course of 6 months.	Patients will be asked to rate shoulder pain from 1-10 at each postoperative visit over the course of 6 months.

Collaborators and Investigators

• Sponsor: University of Mississippi Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Lymphatic Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Cranial Nerve Injuries; Accessory Nerve Diseases; Lymphadenopathy; Accessory Nerve Injuries
• Other Study ID Numbers: 2018-0212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes