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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.

Tracking Information
First Submitted Date March 27, 2019
First Posted Date March 29, 2019
Last Update Posted Date July 2, 2019
Actual Study Start Date July 1, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2019)
  • Graft Mineralization/Fusion [ Time Frame: 12 months ]
    Degree of graft mineralization/fusion for each product via CT scan
  • Graft Mineralization/Fusion [ Time Frame: 6 months ]
    Degree of graft mineralization/fusion for each product via CT scan
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03896347 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 28, 2019)
  • Fusion Rates [ Time Frame: 3, 6, and 12 months ]
    Fusion rates for each product as evidenced by bridging bone via x-ray radiograph
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 11, 2019)
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
Original Other Pre-specified Outcome Measures
 (submitted: March 28, 2019)
Complications and serious adverse reactions [ Time Frame: Through study completion at 12 months ]
Number of participants with ViBone®, GRAFTON®, or INFUSE®-related complications and serious adverse reactions
 
Descriptive Information
Brief Title A Study Evaluating 3-Level OLIF Spine Fusion
Official Title A Randomized Study Evaluating ViBone®, Demineralized Bone Matrix, and Bone Morphogenetic Protein in 3-Level Oblique Lateral Lumbar Interbody Fusion
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.
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Spondylolisthesis
  • Retrolisthesis
  • Degenerative Disc Disease
Intervention
  • Other: ViBone®
    Viable bone allograft
  • Other: Demineralized Bone Matrix
    Demineralized Bone Matrix
  • Other: Bone Morphogenetic Protein
    Bone Morphogenetic Protein
Study Groups/Cohorts
  • 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.
    Interventions:
    • Other: ViBone®
    • Other: Demineralized Bone Matrix
    • Other: 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.
    Interventions:
    • Other: ViBone®
    • Other: Demineralized Bone Matrix
    • Other: 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.
    Interventions:
    • Other: ViBone®
    • Other: Demineralized Bone Matrix
    • Other: Bone Morphogenetic Protein
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 28, 2019)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Stephanie Richardson 678-492-4712 srichardson@aziyo.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03896347
Other Study ID Numbers CLP-0003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Aziyo Biologics, Inc.
Study Sponsor Aziyo Biologics, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Aziyo Biologics, Inc.
Verification Date July 2019