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ViBone in Cervical and Lumbar Spine Fusion

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ClinicalTrials.gov Identifier: NCT03425682
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Aziyo Biologics, Inc.

Brief Summary:
Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.

Condition or disease Intervention/treatment
Spondylosis Cervical Spondylosis Spondylolisthesis Herniated Nucleus Pulposus Degenerative Disc Disease Other: ViBone

Detailed Description:
This study is a prospective, multi-center study to evaluate the clinical and radiographic outcomes of ViBone in patients undergoing ACDF or lumbar interbody fusion. Data will be gathered for up to 50 subjects undergoing ACDF surgery and up to 50 subjects undergoing lumbar fusion surgery using ViBone. Total enrollment is expected to be approximately 100 subjects. The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo 1-3 level ACDF or lumbar interbody fusion surgery using ViBone. Subjects will be followed for 12 months following surgery.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cervical Fusion - ACDF
Up to 50 patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled.
Other: ViBone
Viable Bone Allograft

Lumbar Interbody Fusion
Up to 50 patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled.
Other: ViBone
Viable Bone Allograft




Primary Outcome Measures :
  1. Fusion [ Time Frame: 12 months ]
    Fusion rates for ViBone from surgical procedure


Secondary Outcome Measures :
  1. ODI [ Time Frame: 12 months ]
    Oswestry Disability Index (ODI) improvement relative to baseline for lumbar spine fusion

  2. NDI [ Time Frame: 12 months ]
    Neck Disability Index (NDI) improvement relative to baseline for cervical spine fusion

  3. VAS [ Time Frame: 12 months ]
    Visual Analog Scale (VAS) for pain improvement relative to baseline (Pain scale from 0-10, with 0 being No Pain and 10 being Worst Pain)



Information from the National Library of Medicine

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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
Male and female patients, 18-80 years of age undergoing 1-3 level anterior cervical discectomy fusion (ACDF), or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
Criteria

Inclusion Criteria:

  • Male or female, 18-80 years of age
  • For cervical cases - ACDF surgery at 1, 2, or 3 contiguous levels between C2-C7
  • For lumbar cases - lumbar interbody fusion surgery at 1, 2, or 3 contiguous levels between L1-S1
  • Patient signed Consent Form with HIPAA Authorization
  • Appropriate candidate for surgery
  • Patient will adhere to the scheduled follow-up visits and requirements of the protocol including routine patient exams - pre-operative, operative, and at least two post- operative visits (6 and 12 months post-surgery). Pre-operative and post-operative visits include X-ray (required) and CT scan (if available).

Exclusion Criteria:

  • Long term use of medications that are known to inhibit fusion or bone metabolism or immune suppressants 6 months prior to surgery (i.e., steroids, chemotherapy, DMARDs, etc.)
  • Treatment with radiotherapy
  • Acute or chronic systemic or localized spinal infections
  • Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical (for ACDF patients) or lumbar (for TLIF, PLIF, ALIF, or LLIF patients) spine
  • Previous pseudoarthrosis at any level of the cervical (for ACDF patients) or lumbar (for
  • TLIF, PLIF, ALIF, or LLIF patients) 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 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.
  • Active local or systemic infection or is undergoing adjunctive treatment for local or systemic infection.

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): NCT03425682


Contacts
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Contact: Stephanie Richardson 470-514-4031 srichardson@aziyo.com

Locations
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United States, California
Spine Institute of San Diego Recruiting
San Diego, California, United States, 92120
Contact: Josephine Turner    619-229-5353    jo@siosd.com   
Contact: Stephanie Haua    619-265-7912 ext 3    stephanie@siosd.com   
Principal Investigator: Paul Kim, MD         
Sub-Investigator: Ramin Raiszadeh, MD         
United States, Connecticut
Connecticut Neck & Back Specialists, LLC Recruiting
Danbury, Connecticut, United States, 06810
Contact: Rute Amorim       rca@ctneckandback.com   
Principal Investigator: David A. Bomback, MD, FAAOS         
Sub-Investigator: David L. Kramer, MD, FAAOS         
United States, Maryland
Anne Arundel Medical Group Recruiting
Annapolis, Maryland, United States, 21401
Contact: Brook Fowler, CCRP    443-758-4890    mfowler3@aahs.org   
Principal Investigator: Alessandro Speciale, MD         
Sub-Investigator: Chad Patton, MD         
United States, Minnesota
Summit Orthopedics Withdrawn
Eagan, Minnesota, United States, 55121
United States, Texas
Orthopedic Specialists of Austin Recruiting
Austin, Texas, United States, 78751
Contact: Thomas Redmond       tredmond@orthoaustin.com   
Principal Investigator: Michael Moghimi, MD         
El Paso Spine Center Withdrawn
El Paso, Texas, United States, 79925
SW Orthopedics Withdrawn
Georgetown, Texas, United States, 78626
Sponsors and Collaborators
Aziyo Biologics, Inc.

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Responsible Party: Aziyo Biologics, Inc.
ClinicalTrials.gov Identifier: NCT03425682     History of Changes
Other Study ID Numbers: CLP-0001
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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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 Aziyo Biologics, Inc.:
Anterior Cervical Discectomy and Fusion (ACDF)
Transforaminal Lumbar Interbody Fusion (TLIF)
Posterior Lumbar Interbody Fusion (PLIF)

Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spondylolisthesis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis