ViBone in Cervical and Lumbar Spine Fusion

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425682
• Other study ID #: CLP-0001
• Status: Completed
• Start date: May 14, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2021
• Source: Aziyo Biologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: June 30, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Spondylosis
• Degenerative Disc Disease
• Herniated Nucleus Pulposus
• Intervertebral Disc Degeneration
• Spondylolisthesis
• Spondylosis

Intervention

Other:
• ViBone
Viable Bone Allograft

Locations

Country	Name	City	State
United States	Anne Arundel Medical Group	Annapolis	Maryland
United States	Orthopedic Specialists of Austin	Austin	Texas
United States	Connecticut Neck & Back Specialists, LLC	Danbury	Connecticut
United States	Spine Institute of San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Aziyo Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fusion	Fusion rates for ViBone from surgical procedure	12 months
Secondary	ODI	Oswestry Disability Index (ODI) improvement relative to baseline for lumbar spine fusion	12 months
Secondary	NDI	Neck Disability Index (NDI) improvement relative to baseline for cervical spine fusion	12 months
Secondary	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