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

NCT04684901 | Enrolling By Invitation

• 1 other identifier: AWR-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Stenosis; Spondylolisthesis; Cervical Radiculopathy; Cervical Disc Disorder

Keywords

Anterior Cervical Discectomy and Fusion Surgery; ACDF Surgery

Outcome Measures

Primary Outcomes (1)

• Swelling Index 1 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.

  1 month

Secondary Outcomes (6)

• Swelling Index Other Timepoints

  3, 6 and 12 months

• Neck Disability Index (NDI) Scores

  1, 3, 6 and 12 months

• Visual Analog Scale (VAS) Scores

  1, 3, 6 and 12 months

• Swallowing Quality of Life Questionnaire (SWAL-QOL) Scores

  1, 3, 6 and 12 months

• Air Index Scores

  1, 3, 6 and 12 months

Study Arms (2)

Standard of Care Group

NO INTERVENTION

Standard of Care - No AlloWrap used during surgery

AlloWrap Group

EXPERIMENTAL

AlloWrap used in surgery

Other: AlloWrap® Amniotic Membrane

Interventions

AlloWrap® Amniotic Membrane OTHER

AlloWrap is a human amniotic membrane designed to provide a biologic barrier following surgical repair.

AlloWrap Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• AlloSource: lead

Study Sites (1)

Spine Institute of San Diego

San Diego, California, 92120, United States

Location

MeSH Terms

Conditions

Spondylolisthesis; Radiculopathy

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: January 18, 2021
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)