ViBone in Cervical and Lumbar Spine Fusion

A Prospective, Post-Market, Multi-Center Study Evaluating ViBone® in Cervical and Lumbar Spine Fusion

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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease; Cervical Spondylosis; Spondylosis; Spondylolisthesis; Herniated Nucleus Pulposus
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92120
      • Spine Institute of San Diego
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Connecticut Neck & Back Specialists, LLC
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Group
  • Texas
    • Austin, Texas, United States, 78751
      • Orthopedic Specialists of Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion	Fusion rates for ViBone from surgical procedure	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ODI	Oswestry Disability Index (ODI) improvement relative to baseline for lumbar spine fusion	12 months
NDI	Neck Disability Index (NDI) improvement relative to baseline for cervical spine fusion	12 months
VAS	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)	12 months

Collaborators and Investigators

• Sponsor: Aziyo Biologics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Anterior Cervical Discectomy and Fusion (ACDF); Transforaminal Lumbar Interbody Fusion (TLIF); Posterior Lumbar Interbody Fusion (PLIF)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Intervertebral Disc Degeneration; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: CLP-0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No