NCT03331159

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Johann Wolfgang Goethe University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Fusion of Spine, Lumbar Region

Interventions

Type	Name	Description
DEVICE	NanoBone	Cage was filled with nanocrystalline hydroxyapatite embedded in a silica gel matrix
DEVICE	Homologous Bone	Cage was filled with homologous bone

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-10-31
• Completion: 2015-10-31
• First posted: 2017-11-06
• Last updated: 2017-11-06