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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Stenosis
- Sponsor
- AlloSource
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Swelling Index 1 Month
- Status
- Enrolling By Invitation
- Last Updated
- 5 months ago
Overview
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.
Detailed 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.
Investigators
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Swelling Index 1 Month
Time Frame: 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.
Secondary Outcomes
- Neck Disability Index (NDI) Scores(1, 3, 6 and 12 months)
- Air Index 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)
- Swelling Index Other Timepoints(3, 6 and 12 months)
- Revision Surgery(1, 3, 6 and 12 months)