Spinal Accessory Nerve InjuryNCT03941327
Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections
A study testing AxoGuard Nerve Cuff in people with Spinal Accessory Nerve Injury and Cervical Lymphadenopathy, run by University of Mississippi Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Accessory Nerve Injury, Cervical Lymphadenopathy
- What is being tested?
- AxoGuard Nerve Cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- History of modified radical neck dissection involving removal of spinal accessory nerve or sternocleidomastoid muscle
- History of radical neck dissection
- History of pre- existing disabling shoulder complaints
- <18 years of age
- Any individual unable to provide consent for his/her self.
- Any individual with allergy, sensitivity, or aversion to porcine material.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Gina Jefferson, 312-433-9898, gjefferson@umc.edu
About this study
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.
Read the 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.
- Being tested
- AxoGuard Nerve Cuff
- Medical subject headings
- Accessory Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxoGuard Nerve CuffDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Patients who provide consent for implant placement but do not receive the implant. Receives: Device: AxoGuard Nerve Cuff |
| Interventional | Experimental | Patients who provide consent for implant placement and do receive the implant. Receives: Device: AxoGuard Nerve Cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (1)
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.
Measured: Patients will be asked to rate shoulder pain from 1-10 at each postoperative visit over the course of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 May 2019
- Primary completion1 May 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Accessory Nerve InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941327
- Sponsor's protocol ID
- 2018-0212
- Status last verified
- May 2019
- First submitted
- 1 May 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections
- ClinicalTrials.gov ID
- NCT03941327
- Acronym / sponsor ID
- 2018-0212
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Device: AxoGuard Nerve CuffPatients who provide consent for implant placement but do not receive the implant. |
| Interventional | Experimental | Device: AxoGuard Nerve CuffPatients who provide consent for implant placement and do receive the implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (6 listed)
- History of modified radical neck dissection involving removal of spinal accessory nerve or sternocleidomastoid muscle
- History of radical neck dissection
- History of pre- existing disabling shoulder complaints
- <18 years of age
- Any individual unable to provide consent for his/her self.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AxoGuard Nerve CuffA 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. | Device | Control, Interventional |
Primary outcome
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.
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.
1 secondary outcome
Postoperative pain following neck dissection: rate shoulder pain from 1-10
Time frame: Patients will be asked to rate shoulder pain from 1-10 at each postoperative visit over the course of 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AxoGuard Nerve Cuff in people with Spinal Accessory Nerve Injury and Cervical Lymphadenopathy, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaxon W Jordan, M.D. (325-370-2063, jwjordan@umc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019; AzTrials last refreshed its copy on 28 Oct 2026.