A Study Evaluating 3-Level OLIF Spine Fusion

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo three-level oblique lateral lumbar interbody fusion (OLIF) using ViBone, demineralized bone matrix (DBM), and bone morphogenetic protein (BMP). One product will be used on each level. Subjects will be followed for 12 months following surgery to assess degree of mineralization via computed tomography (CT) scan at 6 and 12 months, mean time to fusion, and maturation of fusion mass postoperatively via x-ray radiograph.

Clinical Trial Description

Up to 120 patients undergoing three-level OLIF using ViBone, DBM, and BMP each on separate levels will be enrolled. Implantation of ViBone, DBM, and BMP will be randomized between the three levels. Subjects will be followed for a total of 12 months. Data and x-ray radiographs will be collected according to standard of care, including baseline, 3, 6, and 12 months post-surgery. Additionally, a CT scan will be required at 6 and 12 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03896347
Study type	Observational
Source	Aziyo Biologics, Inc.
Contact
Status	Withdrawn
Phase
Start date	July 1, 2019
Completion date	February 13, 2020

View Details

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