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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Radiographically diagnosed with cervical stenosis or cervical disc disorder and/or degeneration, spondylolisthesis and/or cervical radiculopathy resulting from neural element compression as confirmed by MRI, CT, CT myelogram
Failed to gain adequate relief from non-operative treatment, including but not limited to medications, physical therapy, chiropractic care, home exercise and/or for at least 6 weeks; or the patient has progressive muscle weakness or atrophy or intractable pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6 and 12 months
Awards & highlights
Study Summary
This trial is testing whether using a type of amniotic membrane called AlloWrap can reduce swelling in the soft tissues around the spine after a two-level ACDF surgery.
Who is the study for?
This trial is for adults over 18 with cervical spine issues like stenosis or disc disorders, who haven't found relief through non-surgical treatments. They must understand the study and be scheduled for a specific spinal fusion surgery. Exclusions include those with certain bone diseases, recent steroid injections or NSAIDs use, major health risks, recent substance abuse treatment, other clinical trials participation within 90 days, infections including HIV/Hepatitis B/C, mental impairment affecting study compliance, immune system issues requiring treatment like chemotherapy or radiation therapy.Check my eligibility
What is being tested?
The trial tests AlloWrap Amniotic Membrane's effectiveness in reducing soft tissue swelling after two-level Anterior Cervical Discectomy and Fusion (ACDF) procedures. Participants will receive this membrane during their scheduled surgery to see if it helps decrease inflammation better than standard surgical practices without AlloWrap.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include typical surgical risks such as infection at the site of implantation of AlloWrap®, allergic reactions to the amniotic material used in AlloWrap®, and complications related to ACDF procedures such as difficulty swallowing or hoarseness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a neck condition or nerve compression confirmed by an MRI or CT scan.
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I haven't found relief from non-surgical treatments for over 6 weeks, or I have worsening muscle weakness or unbearable pain.
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I have nerve problems or pain that spreads from my spine.
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I am scheduled for a neck surgery involving a specific type of implant.
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I am an adult over 18, not pregnant or breastfeeding, and my bones have stopped growing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3, 6 and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6 and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Swelling Index 1 Month
Secondary outcome measures
Air Index Scores
Neck Disability Index (NDI) Scores
Revision Surgery
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AlloWrap GroupExperimental Treatment1 Intervention
AlloWrap used in surgery
Group II: Standard of Care GroupActive Control1 Intervention
Standard of Care - No AlloWrap used during surgery
Find a Location
Who is running the clinical trial?
AlloSourceLead Sponsor
7 Previous Clinical Trials
330 Total Patients Enrolled
Jill BagdasarianStudy DirectorAlloSource
2 Previous Clinical Trials
82 Total Patients Enrolled
Elizabeth Esterl, DNP, MS, RNStudy DirectorAlloSource
2 Previous Clinical Trials
82 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery on my neck before.I need surgery to join two or more of my neck bones due to symptoms.I have inflammation in the neck bones.I have a history of an autoimmune disease like lupus, Crohn's, or rheumatoid arthritis.I do not have an active infection or HIV, Hepatitis B, or C.You have been treated for alcohol or drug abuse in a program within the last 6 months.I need surgery on the back of my neck at the same time as my anterior cervical surgery.I have been diagnosed with a neck condition or nerve compression confirmed by an MRI or CT scan.I have a neck deformity due to a past injury or tumor.You have a medical reason that makes it unsafe for you to have an MRI scan.I do not have unstable heart, kidney, liver, hormone disorders, lung diseases, cancer, or uncontrolled diabetes.I have had or plan to have a spinal injection or have taken anti-inflammatory drugs within a week before surgery.I had a neck injury less than 6 months ago.I haven't found relief from non-surgical treatments for over 6 weeks, or I have worsening muscle weakness or unbearable pain.I have a condition like osteoporosis that affects my bones' ability to heal.I have nerve problems or pain that spreads from my spine.I am scheduled for a neck surgery involving a specific type of implant.I am not currently being treated for a mental health condition that would affect my ability to participate in a study.I have no active cancer, except for non-melanoma skin cancer, or any signs of cancer for 5 years.I am currently immunocompromised or need treatment that weakens my immune system.I do not have heart or lung problems that make surgery too risky.I am an adult over 18, not pregnant or breastfeeding, and my bones have stopped growing.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Group
- Group 2: AlloWrap Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies for this clinical examination yet?
"Clinicaltrials.gov shows that this clinical trial is actively enrolling participants, having been first posted on the 18th of January 2021 and most recently updated on the 26th of January 2022."
Answered by AI
What is the maximum capacity for participants in this research experiment?
"Affirmative. According to clinicaltrials.gov, this clinical trial is presently recruiting participants who can be traced back to its original posting date of January 18th 2021 and most recent update on January 26th 2022. The study aspires to select 50 individuals from a single location for participation."
Answered by AI
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