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

Spondylolisthesis Clinical Trial

Official title:

A Randomized, Controlled Study to Evaluate Effectiveness of AlloWrap® Amniotic Membrane for the Reduction of Post-Operative Soft Tissue Inflammation in Two-Level Anterior Cervical Discectomy and Fusion Procedures

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04684901
• Other study ID #: AWR-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: January 2026

Study information

• Verified date: May 2024
• Source: AlloSource
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

AlloWrap® is a dual sided human amniotic membrane, procured from consented human tissue donors who elect to have scheduled cesarean births. A Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) as defined by the United States Food and Drug Administration (FDA) 21 CFR Part 1271, AlloWrap® is intended to provide a biologic barrier following surgical repair. Designed to meet the clinical needs of the patient and practical needs of the clinical setting amniotic based surgical barriers have been shown to contain a natural balance of cytokines that can assist the body in reducing epidural fibrosis, inflammation, and infection at the surgical site. Using AlloWrap® as a surgical barrier may result in outcomes with less scaring, potentially reducing pain and assisting the patient in returning to normal functionality while potentially making revision dissections less complicated. The purpose of this clinical study is to evaluate the use of AlloWrap® Amniotic Membrane in ACDF procedures to obtain evidence of effectiveness, defined as the reduction, and the possible prevention, of complications associated with ACDF surgery such as odynophagia and/or dysphasia that result from soft tissue inflammation.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: January 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 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.

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Cervical Stenosis
• Inflammation
• Radiculopathy
• Spondylolisthesis

Intervention

Other:
• AlloWrap® Amniotic Membrane
AlloWrap is a human amniotic membrane designed to provide a biologic barrier following surgical repair.

Locations

Country	Name	City	State
United States	Spine Institute of San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
AlloSource

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Swelling Index Other Timepoints	Difference of change from baseline to discharge, 3, 6 and 12 months post operatively of soft tissue thickness/swelling, as measured by the swelling index on lateral x-rays	3, 6 and 12 months
Secondary	Neck Disability Index (NDI) Scores	The comparisons of score changes between groups at each timepoint will be investigated by employing linear regression	1, 3, 6 and 12 months
Secondary	Visual Analog Scale (VAS) Scores	The comparisons of score changes between groups at each timepoint will be investigated by employing linear regression	1, 3, 6 and 12 months
Secondary	Swallowing Quality of Life Questionnaire (SWAL-QOL) Scores	The comparisons of score changes between groups at each timepoint will be investigated by employing linear regression	1, 3, 6 and 12 months
Secondary	Air Index Scores	The comparisons of score changes for 1, 3, 6, and 12 months from baseline will be investigated by using linear regression	1, 3, 6 and 12 months
Secondary	Revision Surgery	The numbers and percentages of patients who underwent revision surgery as of each timepoint	1, 3, 6 and 12 months