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AlloWrap for Post-ACDF Inflammation

N/A
Waitlist Available
Research Sponsored by AlloSource
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
Must not have
Has had prior cervical spine surgery
Have symptomatic disease requiring fusion of one level or > 2 levels and/or requiring fusion between levels C2-C4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6 and 12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery on my neck before.
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I need surgery to join two or more of my neck bones due to symptoms.
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I have inflammation in the neck bones.
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I have a history of an autoimmune disease like lupus, Crohn's, or rheumatoid arthritis.
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I do not have an active infection or HIV, Hepatitis B, or C.
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I need surgery on the back of my neck at the same time as my anterior cervical surgery.
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I have a neck deformity due to a past injury or tumor.
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I do not have unstable heart, kidney, liver, hormone disorders, lung diseases, cancer, or uncontrolled diabetes.
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I have a condition like osteoporosis that affects my bones' ability to heal.
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I am not currently being treated for a mental health condition that would affect my ability to participate in a study.
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I am currently immunocompromised or need treatment that weakens my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Swelling Index 1 Month
Secondary study objectives
Air Index Scores
Neck Disability Index (NDI) Scores
Revision Surgery
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
8 Previous Clinical Trials
545 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

Media Library

AlloWrap® Amniotic Membrane (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04684901 — N/A
Spondylolisthesis Research Study Groups: Standard of Care Group, AlloWrap Group
Spondylolisthesis Clinical Trial 2023: AlloWrap® Amniotic Membrane Highlights & Side Effects. Trial Name: NCT04684901 — N/A
AlloWrap® Amniotic Membrane (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04684901 — N/A
~5 spots leftby Jun 2025
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