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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04684901
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : January 28, 2022
Sponsor:
Information provided by (Responsible Party):
AlloSource

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.

Condition or disease Intervention/treatment Phase
Cervical Stenosis Spondylolisthesis Cervical Radiculopathy Other: AlloWrap® Amniotic Membrane Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 18, 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
No Intervention: Standard of Care Group
Standard of Care - No AlloWrap used during surgery
Experimental: AlloWrap Group
AlloWrap used in surgery
Other: AlloWrap® Amniotic Membrane
AlloWrap is a human amniotic membrane designed to provide a biologic barrier following surgical repair.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Swelling Index Other Timepoints [ Time Frame: 3, 6 and 12 months ]
    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

  2. Neck Disability Index (NDI) Scores [ Time Frame: 1, 3, 6 and 12 months ]
    The comparisons of score changes between groups at each timepoint will be investigated by employing linear regression

  3. Visual Analog Scale (VAS) Scores [ Time Frame: 1, 3, 6 and 12 months ]
    The comparisons of score changes between groups at each timepoint will be investigated by employing linear regression

  4. Swallowing Quality of Life Questionnaire (SWAL-QOL) Scores [ Time Frame: 1, 3, 6 and 12 months ]
    The comparisons of score changes between groups at each timepoint will be investigated by employing linear regression

  5. Air Index Scores [ Time Frame: 1, 3, 6 and 12 months ]
    The comparisons of score changes for 1, 3, 6, and 12 months from baseline will be investigated by using linear regression

  6. Revision Surgery [ Time Frame: 1, 3, 6 and 12 months ]
    The numbers and percentages of patients who underwent revision surgery as of each timepoint



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684901


Contacts
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Contact: Claire McFadyen, MPH 720. 873. 2452 cmcfadyen@allosource.org
Contact: Elizabeth Esterl, DNP, MS, RN 720. 732.6231 eesterl@allosource.org

Locations
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United States, California
Spine Institute of San Diego Recruiting
San Diego, California, United States, 92120
Contact: Paul D Kim, MD    619-265-7912 ext 3    paul@siosd.com   
Sponsors and Collaborators
AlloSource
Investigators
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Study Director: Elizabeth Esterl, DNP, MS, RN AlloSource
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Responsible Party: AlloSource
ClinicalTrials.gov Identifier: NCT04684901    
Other Study ID Numbers: AWR-001
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: January 28, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AlloSource:
Anterior Cervical Discectomy and Fusion Surgery
ACDF Surgery
Additional relevant MeSH terms:
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Spondylolisthesis
Radiculopathy
Inflammation
Pathologic Processes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases