NCT03896347

A Study Evaluating 3-Level OLIF Spine Fusion

A Randomized Study Evaluating ViBone®, Demineralized Bone Matrix, and Bone Morphogenetic Protein in 3-Level Oblique Lateral Lumbar Interbody Fusion

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Elutia Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Spondylolisthesis
• Retrolisthesis
• Degenerative Disc Disease

Interventions

Type	Name	Description
OTHER	ViBone®	Viable bone allograft
OTHER	Demineralized Bone Matrix	Demineralized Bone Matrix
OTHER	Bone Morphogenetic Protein	Bone Morphogenetic Protein

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-02-07
• Completion: 2020-02-13
• First posted: 2019-03-29
• Last updated: 2023-07-20