NCT03425682

ViBone in Cervical and Lumbar Spine Fusion

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 118 (actual)
• Sponsor: Elutia Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 subjects undergoing ACDF surgery and 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.

Conditions

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

Interventions

Type	Name	Description
OTHER	ViBone	Viable Bone Allograft

Timeline

• Start date: 2018-05-14
• Primary completion: 2021-01-15
• Completion: 2021-06-30
• First posted: 2018-02-07
• Last updated: 2025-03-04
• Results posted: 2025-03-04

Locations

4 sites across 1 country: United States