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出境医 / 临床实验 / Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections
Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Accessory Nerve Injury Cervical Lymphadenopathy | Device: AxoGuard Nerve Cuff | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Masking Description: | Patients will be randomly assigned to a control group or intervention group using a computer based randomization tool. Patient's undergoing bilateral neck dissection will receive an implant on one side and act as self control. |
| Primary Purpose: | Prevention |
| Official Title: | Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections |
| Actual Study Start Date : | May 1, 2019 |
| Estimated Primary Completion Date : | May 1, 2020 |
| Estimated Study Completion Date : | May 1, 2020 |
Arms and Interventions
| 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.
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|
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.
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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. ]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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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:
- 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.
Contacts and Locations
Contacts
| Contact: Jaxon W Jordan, M.D. | 325-370-2063 | jwjordan@umc.edu | |
| Contact: Gina Jefferson, M.D. | 3124339898 | gjefferson@umc.edu |
Locations
| United States, Mississippi | |
| University of Mississippi Medical Center | Recruiting |
| Jackson, Mississippi, United States, 39216 | |
| Contact: Gina Jefferson 312-433-9898 gjefferson@umc.edu | |
Sponsors and Collaborators
University of Mississippi Medical Center
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 1, 2019 | ||||
| First Posted Date ICMJE | May 7, 2019 | ||||
| Last Update Posted Date | May 7, 2019 | ||||
| Actual Study Start Date ICMJE | May 1, 2019 | ||||
| Estimated Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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. ] 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.
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections | ||||
| Official Title ICMJE | Do AxoGuard Implants Decrease Shoulder Disability After Neck Dissections | ||||
| 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. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Masking Description: Patients will be randomly assigned to a control group or intervention group using a computer based randomization tool. Patient's undergoing bilateral neck dissection will receive an implant on one side and act as self control. Primary Purpose: Prevention
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| Condition ICMJE |
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| Intervention ICMJE | 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.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
100 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | May 1, 2020 | ||||
| Estimated Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
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:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03941327 | ||||
| Other Study ID Numbers ICMJE | 2018-0212 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | University of Mississippi Medical Center | ||||
| Study Sponsor ICMJE | University of Mississippi Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | University of Mississippi Medical Center | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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