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Status Withdrawn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Status	Withdrawn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

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04848376` - Post-Market Clinical Follow-up Study of A-SPINE's Products
Active, not recruiting	`NCT05114135` - TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)	N/A
Suspended	`NCT04735185` - Stem Cells vs. Steroids for Discogenic Back Pain	N/A
Withdrawn	`NCT03223701` - Efficacy of Using Solum IV and BMC With GFC in TLIF	Phase 4
Completed	`NCT04057235` - Retrospective Review of Integrity Implants FlareHawk® for Lumbar Fusion
Not yet recruiting	`NCT06000319` - Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
Active, not recruiting	`NCT02969616` - Trinity Elite in Lumbar Fusion
Completed	`NCT02558621` - New Robotic Assistance System for Spinal Fusion Surgery	N/A
Completed	`NCT02104167` - Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
Completed	`NCT00996073` - Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion	Phase 2
Terminated	`NCT00974623` - Bone Graft Materials Observational Registry	N/A
Completed	`NCT00965380` - Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
Completed	`NCT00758719` - Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
Completed	`NCT00165893` - Comparison of IDD Therapy and Non-surgical Treatment for Low Back Pain Caused by Degenerative Disc Disease	Phase 4
Terminated	`NCT01494493` - Pivotal Study of rhBMP-2/ACS/Allograft Bone Dowel for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease	N/A
Recruiting	`NCT04727385` - Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease	N/A
Completed	`NCT04849429` - Intra-discal Injection of Platelet-rich Plasma (PRP) Enriched With Exosomes in Chronic Low Back Pain	Phase 1
Recruiting	`NCT04469387` - Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion	N/A
Recruiting	`NCT04056520` - Clinical and Radiological Outcomes of Posterior Cervical Fusion With Medtronic Infinity Occipitocervical-Upper Thoracic (OCT) System
Completed	`NCT04119466` - Stabilizing Training in Degenerative Disc Disease	N/A