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AlloWrap® for Reducing Inflammation in ACDF Procedures

This study is looking at how well a product called AlloWrap® Amniotic Membrane works to reduce swelling after a neck surgery called ACDF (Anterior Cervical Discectomy and Fusion). AlloWrap® is a special barrier made from human amniotic membrane, which comes from consented donors after scheduled C-sections. It's designed to help reduce inflammation and scarring at the surgical site. The study aims to see if using AlloWrap® can help prevent problems like difficulty swallowing that can happen due to swelling after ACDF surgery. You might be able to join if you are at least 18 years old, not pregnant or breastfeeding, and have been diagnosed with conditions like cervical stenosis (narrowing of the spinal canal in the neck) or cervical disc disorder, often with nerve symptoms. The main way they will measure success is by checking swelling one month after surgery. The current status of this study is unclear, and it plans to enroll about 50 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one month after treatment to measure swelling.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04684901

Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures

Enrolling by Invitation
NAAges 18+InterventionalTreatment
AlloSource
~50 participants
Updated 2025-11-21 on ClinicalTrials.gov
What's tested:AlloWrap® Amniotic Membrane

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Swelling Index 1 Month
Measured over 1 month

Conditions

Cervical Stenosis
Spondylolisthesis
Cervical Radiculopathy
Cervical Disc Disorder

Explore related trials

Cervical disc disorderCervical radiculopathyIntractable PainMuscle AtrophyMuscle WeaknessNeurologic DysfunctionSpinal stenosis in cervical regionSpondylolisthesis

Where it's being run

1 sites across 1 states
California1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Be a skeletally mature male or a non-pregnant, non-lactating female ≥18 years of age;
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;
Neurological dysfunction or radicular symptoms by history and physical exam;
Is scheduled/or will be scheduled to undergo an anterior cervical fusion, requiring internal fixation using an anterior cervical standalone interbody cage system;
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;
Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.

Exclusion

Have a documented medical history or radiographic evidence of osteoporosis or other condition which would negatively impact the bone healing process (e.g. history of Paget's disease, osteomalacia, or other osteodystrophy) or preclude the subject from receiving screw fixation;
Have had or plans to have an epidural steroid injection or has taken NSAIDs ≤ 7 days prior to surgery;
Circulatory, cardiac, or pulmonary problems that could cause excessive surgical risk based on the opinion of the Investigator;
Active malignancy; Nondiscogenic source of symptoms (e.g., tumor, etc.) or undergoing treatment for tumor or boney traumatic injury to the cervical spine or a history of any invasive malignancy (except non-melanoma skin cancer), unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years;
Acute cervical trauma ≤ 6 months prior to surgery;
Inflammatory disease of the cervical spine;
Has a history of substance abuse (recreational drugs, alcohol) that has been treated in the last 6 months before enrollment for alcohol and/or drug abuse in an in-patient substance abuse program;
Is currently involved in a study of another investigational product for similar purpose or has been in the previous 90 days;
Active infection at the operative level, or a systemic infection including prior or pending treatment for HIV, Hepatitis B or Hepatitis C;
Mentally compromised (e.g., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his or her ability to participate in the clinical study;
Currently immunologically suppressed or immunocompromised, or a medical condition requiring radiation, chemotherapy or immunosuppression;
Subjects who, in the opinion of the Investigator, would not be able or willing to comply with the protocol;
Have a history of any autoimmune disease, such as, systemic lupus erythematosus (SLE), Addison's disease, Crohn's disease, multiple sclerosis or rheumatoid arthritis;
Has had prior cervical spine surgery;
Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer or uncontrolled diabetes;
Have symptomatic disease requiring fusion of one level or \> 2 levels and/or requiring fusion between levels C2-C4;
Has cervical deformity secondary to acute or chronic traumatic fracture or neoplasm, including vertebral, facet or posterior element fracture or dislocation;
Requires a concomitant posterior cervical surgery at the time of the ACDF;
Has any contraindications for MRI;
Is a ward of the state, prisoner, or transient.

What this trial measures

  • Swelling Index 1 Month1 month

    Difference of change from baseline to 1 month post operatively of soft tissue thickness/swelling, as measured by the swelling index on lateral x-rays.