Evaluation of Fusion After ALIF With an Osteoinductive Material or With Homologus Bone

Fusion of Spine, Lumbar Region Clinical Trial

Official title:
Evaluation of Fusion After Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material: a First Randomized Clinical Trial

Status Completed

Clinical Trial Summary

The aim of this study was to determine whether instrumented anterior lumbar interbody Fusion with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) was associated with superior radiological and clinical outcomes at 12 months follow-up compared with instrumented ALIF with homologous bone

Clinical Trial Description

This randomized clinical trial included two groups of 20 mature patients with mono- or multisegmental degenerative disease of the lumbar spine who were suitable to undergo mono- or bisegmental ALIF fusion at the level L4/L5 and L5/S1 with a carbon fiber reinforced polymer ALIF cage filled with either NH-SiO2 or homologous bone (HB). Patients were followed 12 months postoperatively. The primary aim was to compare postoperative disability as measured by the Oswestry Disability Index (ODI). Secondary aims were to compare postoperative radiographic outcomes and differences in pain and quality of life between these groups. ;

Study Design

Related Conditions & MeSH terms

Fusion of Spine, Lumbar Region

Clinical Trial Details

NCT number	NCT03331159
Study type	Interventional
Source	Johann Wolfgang Goethe University Hospital
Contact
Status	Completed
Phase	N/A
Start date	July 1, 2012
Completion date	October 31, 2015

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See also
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