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A Study Evaluating 3-Level OLIF Spine Fusion

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ClinicalTrials.gov Identifier: NCT03896347
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Aziyo Biologics, Inc.

Brief Summary:
The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo three-level oblique lateral lumbar interbody fusion (OLIF) using ViBone, demineralized bone matrix (DBM), and bone morphogenetic protein (BMP). One product will be used on each level. Subjects will be followed for 12 months following surgery to assess degree of mineralization via computed tomography (CT) scan at 6 and 12 months, mean time to fusion, and maturation of fusion mass postoperatively via x-ray radiograph.

Condition or disease Intervention/treatment
Spondylolisthesis Retrolisthesis Degenerative Disc Disease Other: ViBone® Other: Demineralized Bone Matrix Other: Bone Morphogenetic Protein

Detailed Description:

Up to 120 patients undergoing three-level OLIF using ViBone, DBM, and BMP each on separate levels will be enrolled.

Implantation of ViBone, DBM, and BMP will be randomized between the three levels.

Subjects will be followed for a total of 12 months. Data and x-ray radiographs will be collected according to standard of care, including baseline, 3, 6, and 12 months post-surgery. Additionally, a CT scan will be required at 6 and 12 months.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Randomized Study Evaluating ViBone®, Demineralized Bone Matrix, and Bone Morphogenetic Protein in 3-Level Oblique Lateral Lumbar Interbody Fusion
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ViBone®
One product will be used on each level. At the time of surgery, implantation of ViBone®, DBM, and BMP will be randomized between the three treated levels.
Other: ViBone®
Viable bone allograft

Other: Demineralized Bone Matrix
Demineralized Bone Matrix

Other: Bone Morphogenetic Protein
Bone Morphogenetic Protein

Demineralized Bone Matrix
One product will be used on each level. At the time of surgery, implantation of ViBone®, DBM, and BMP will be randomized between the three treated levels.
Other: ViBone®
Viable bone allograft

Other: Demineralized Bone Matrix
Demineralized Bone Matrix

Other: Bone Morphogenetic Protein
Bone Morphogenetic Protein

Bone Morphogenetic Protein
One product will be used on each level. At the time of surgery, implantation of ViBone®, DBM, and BMP will be randomized between the three treated levels.
Other: ViBone®
Viable bone allograft

Other: Demineralized Bone Matrix
Demineralized Bone Matrix

Other: Bone Morphogenetic Protein
Bone Morphogenetic Protein




Primary Outcome Measures :
  1. Graft Mineralization/Fusion [ Time Frame: 12 months ]
    Degree of graft mineralization/fusion for each product via CT scan

  2. Graft Mineralization/Fusion [ Time Frame: 6 months ]
    Degree of graft mineralization/fusion for each product via CT scan


Secondary Outcome Measures :
  1. Fusion Rates [ Time Frame: 3, 6, and 12 months ]
    Fusion rates for each product as evidenced by bridging bone via x-ray radiograph

  2. Time to Fusion [ Time Frame: 3, 6, and 12 months ]
    Time to fusion for each product as evidenced by bridging bone via x-ray radiograph


Other Outcome Measures:
  1. Complications and serious adverse reactions [ Time Frame: Through study completion at 12 months ]
    Number of participants with ViBone®, DBM, or BMP-related complications and serious adverse reactions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Up to 120 male and female OLIF patients at up to 5 centers in the United States will be enrolled.
Criteria

Inclusion Criteria

  • Male or female, 18-80 years of age
  • Patient must have degenerative disc disease, defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies, affecting three contiguous levels between L2 and S1. Affected levels may also have up to Grade 1 spondylolisthesis or retrolisthesis
  • Patient must have at least 6 months on non-operative treatment prior to study enrollment
  • Patient signed Informed Consent Form
  • Patient signed HIPAA Authorization (may be part of the ICF)
  • Appropriate candidate for OLIF surgery using ViBone®, DBM, and BMP)
  • Patient will adhere to the scheduled follow-up visits and requirements of the protocol
  • Routine patient exams include pre-operative, operative, and three post-operative visits (3, 6, and 12 months post-surgery)
  • CT scan of surgical site 6 and 12 months post-surgery

Exclusion Criteria

  • Long-term, chronic use of medications that are known to inhibit fusion, bone metabolism, or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.)
  • Treatment with radiotherapy
  • Patients who have who have had surgery for primary tumors or metastatic malignant tumors of the lumbar or sacral spine
  • Nursing mothers or women who are pregnant or plan to become pregnant during the course of the study
  • Current or recent history of malignancy or infectious disease. Patients with current or recent history of basal cell carcinoma are eligible.
  • Inability to provide informed consent
  • Rapid joint disease, bone absorption, osteomalacia, and/or diagnosed osteoporosis (bone density test score of <-2.5).
  • Other medical or surgical conditions which would preclude the potential benefit of surgery, such as congenital abnormalities, immunosuppressive disease, elevation of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count.
  • Morbid obesity as defined by a body mass index (BMI) of 40 or greater
  • Patients with an allergy to titanium or titanium alloy
  • Patients who are skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure)
  • Active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection.
  • Patients with a known hypersensitivity to recombinant Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation of the BMP

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): NCT03896347


Contacts
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Contact: Stephanie Richardson 678-492-4712 srichardson@aziyo.com

Locations
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United States, Tennessee
Expert Spine Care Recruiting
Nashville, Tennessee, United States, 37203
Contact: Lynn Peterson       speterso@ascension.org   
Contact: Bryan Davis       bryanmedical25@gmail.com   
Principal Investigator: Joseph Blythe, DO         
Sponsors and Collaborators
Aziyo Biologics, Inc.

Additional Information:
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Responsible Party: Aziyo Biologics, Inc.
ClinicalTrials.gov Identifier: NCT03896347     History of Changes
Other Study ID Numbers: CLP-0003
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Aziyo Biologics, Inc.:
OLIF
ViBone
DBM
BMP
DDD
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spondylolisthesis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis