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

Not Applicable

• Conditions: Cervical Stenosis; Spondylolisthesis; Cervical Radiculopathy; Cervical Disc Disorder

• Registration Number: NCT04684901
• Lead Sponsor: AlloSource

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria:<br><br> - Be a skeletally mature male or a non-pregnant, non-lactating female =18 years of<br> age;<br><br> - Radiographically diagnosed with cervical stenosis or cervical disc disorder and/or<br> degeneration, spondylolisthesis and/or cervical radiculopathy resulting from neural<br> element compression as confirmed by MRI, CT, CT myelogram;<br><br> - Neurological dysfunction or radicular symptoms by history and physical exam;<br><br> - Is scheduled/or will be scheduled to undergo an anterior cervical fusion, requiring<br> internal fixation using an anterior cervical standalone interbody cage system;<br><br> - Failed to gain adequate relief from non-operative treatment, including but not<br> limited to medications, physical therapy, chiropractic care, home exercise and/or<br> for at least 6 weeks; or the patient has progressive muscle weakness or atrophy or<br> intractable pain;<br><br> - Have the ability to understand the requirements of the study, to provide written<br> informed consent, and to comply with the study protocol.<br><br>Exclusion Criteria:<br><br> - Have a documented medical history or radiographic evidence of osteoporosis or other<br> condition which would negatively impact the bone healing process (e.g. history of<br> Paget's disease, osteomalacia, or other osteodystrophy) or preclude the subject from<br> receiving screw fixation;<br><br> - Have had or plans to have an epidural steroid injection or has taken NSAIDs = 7 days<br> prior to surgery;<br><br> - Circulatory, cardiac, or pulmonary problems that could cause excessive surgical risk<br> based on the opinion of the Investigator;<br><br> - Active malignancy; Nondiscogenic source of symptoms (e.g., tumor, etc.) or<br> undergoing treatment for tumor or boney traumatic injury to the cervical spine or a<br> history of any invasive malignancy (except non-melanoma skin cancer), unless the<br> patient has been treated with curative intent and there have been no clinical signs<br> or symptoms of the malignancy for at least 5 years;<br><br> - Acute cervical trauma = 6 months prior to surgery;<br><br> - Inflammatory disease of the cervical spine;<br><br> - Has a history of substance abuse (recreational drugs, alcohol) that has been treated<br> in the last 6 months before enrollment for alcohol and/or drug abuse in an<br> in-patient substance abuse program;<br><br> - Is currently involved in a study of another investigational product for similar<br> purpose or has been in the previous 90 days;<br><br> - Active infection at the operative level, or a systemic infection including prior or<br> pending treatment for HIV, Hepatitis B or Hepatitis C;<br><br> - Mentally compromised (e.g., being currently treated for a psychiatric disorder,<br> senile dementia, Alzheimer's disease) in a manner that would compromise his or her<br> ability to participate in the clinical study;<br><br> - Currently immunologically suppressed or immunocompromised, or a medical condition<br> requiring radiation, chemotherapy or immunosuppression;<br><br> - Subjects who, in the opinion of the Investigator, would not be able or willing to<br> comply with the protocol;<br><br> - Have a history of any autoimmune disease, such as, systemic lupus erythematosus<br> (SLE), Addison's disease, Crohn's disease, multiple sclerosis or rheumatoid<br> arthritis;<br><br> - Has had prior cervical spine surgery;<br><br> - Unstable cardiovascular, renal, hepatic, endocrine and/or pulmonary disease, cancer<br> or uncontrolled diabetes;<br><br> - Have symptomatic disease requiring fusion of one level or > 2 levels and/or<br> requiring fusion between levels C2-C4;<br><br> - Has cervical deformity secondary to acute or chronic traumatic fracture or neoplasm,<br> including vertebral, facet or posterior element fracture or dislocation;<br><br> - Requires a concomitant posterior cervical surgery at the time of the ACDF;<br><br> - Has any contraindications for MRI;<br><br> - Is a ward of the state, prisoner, or transient.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Swelling Index 1 Month

Secondary Outcome Measures

Name	Time	Method
Swelling Index Other Timepoints;Neck Disability Index (NDI) Scores;Visual Analog Scale (VAS) Scores;Swallowing Quality of Life Questionnaire (SWAL-QOL) Scores;Air Index Scores;Revision Surgery