ViBone in Cervical and Lumbar Spine Fusion

NCT03425682 | Completed Results

• 1 other identifier: CLP-0001
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 4

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.

Conditions

Spondylosis; Cervical Spondylosis; Spondylolisthesis; Herniated Nucleus Pulposus; Degenerative Disc Disease

Keywords

Anterior Cervical Discectomy and Fusion (ACDF); Transforaminal Lumbar Interbody Fusion (TLIF); Posterior Lumbar Interbody Fusion (PLIF)

Outcome Measures

Primary Outcomes (1)

• Fusion Rates Per Level Using the Bridwell Interbody Grading Scale

  Successful fusion rates for ViBone as defined by Grade I or II level of fusion on the Bridwell Interbody Grading Scale (below). The percentages below show at 12 months the amount of fusion per level for cervical and lumbar fusion procedures utilizing ViBone. Grade I: Fused with remodeling and trabeculae present. Grade II: Graft intact, not fully remodeled and incorporated, but no lucency present. Grade III: Graft intact, potential lucency present at top and bottom of graft. Grade IV: Fusion absent with collapse/resorption of graft.

  12 months

Secondary Outcomes (3)

• Percent Change From Baseline in Oswestry Disability Index (ODI) at 12 Months

  Baseline and 12 months

• Percent Change From Baseline in Neck Disability Index (NDI) at 12 Months

  Baseline and 12 months

• Percent Change From Baseline in Visual Analog Scale (VAS) at 12 Months

  Baseline and 12 months

Study Arms (2)

Cervical Fusion - ACDF

Patients undergoing anterior cervical discectomy and fusion (ACDF) using ViBone will be enrolled.

Other: ViBone

Lumbar Interbody Fusion

Patients undergoing lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone will also be enrolled.

Other: ViBone

Interventions

ViBone OTHER

Viable Bone Allograft

Cervical Fusion - ACDF; Lumbar Interbody Fusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elutia Inc.: lead

Study Sites (4)

Spine Institute of San Diego

San Diego, California, 92120, United States

Location

Connecticut Neck & Back Specialists, LLC

Danbury, Connecticut, 06810, United States

Location

Anne Arundel Medical Group

Annapolis, Maryland, 21401, United States

Location

Orthopedic Specialists of Austin

Austin, Texas, 78751, United States

Location

Related Publications (1)

• Kim PD, Raiszadeh R, Bomback DA, Kramer DL, Moghimi M. 12-Month clinical and radiographic outcomes of ViBone viable bone matrix in patients undergoing cervical and lumbar spinal fusion surgery. J Orthop Surg Res. 2023 Mar 25;18(1):239. doi: 10.1186/s13018-023-03686-9.

  PMID: 36964582 DERIVED

MeSH Terms

Conditions

Spondylosis; Spondylolisthesis; Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis

Results Point of Contact

• Title: Associate Director, Clinical Operations
• Organization: Aziyo Biologics, Inc.

srichardson@aziyo.com

678-492-4712

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 7, 2018
• Study Start: May 14, 2018
• Primary Completion: January 15, 2021
• Study Completion: June 30, 2021
• Last Updated: March 4, 2025
• Results First Posted: March 4, 2025

Record last verified: 2025-02

Locations

US (4)