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

  • End date
    Jun 25, 2023
  • participants needed
  • sponsor
Updated on 25 March 2022
intractable pain
cervical fusion
cervical radiculopathy


The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue swelling in two-level ACDF procedures.

Condition Cervical Stenosis, Spondylolisthesis, Cervical Radiculopathy
Treatment AlloWrap® Amniotic Membrane
Clinical Study IdentifierNCT04684901
Last Modified on25 March 2022


Yes No Not Sure

Inclusion Criteria

Be a skeletally mature male or a non-pregnant, non-lactating female ≥18 years of age
Radiographically diagnosed with cervical stenosis and/or degeneration, spondylolisthesis and/or cervical radiculopathy resulting from neural element compression as confirmed by MRI, CT, CT myelogram
Radicular symptoms by history and physical exam
Neck disability Index ≥30 points on a 0-50 pt scale
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 Criteria

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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