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

Not Applicable

Completed

• Conditions: Fusion of Spine, Lumbar Region
• Interventions: Device: Homologous Bone; Device: NanoBone

• Registration Number: NCT03331159
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief 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.

Study Timeline

• Study Start: 2012-07-01
• Primary Completion: 2013-10-31
• Study Completion: 2015-10-31
• Status Verified: 2017-10
• Study First Submitted: 2017-10-29
• Study First Submitted QC: 2017-10-31
• Last Update Submitted: 2017-10-31
• Study First Posted: 2017-11-06
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• chronic low back pain
• sensorimotor deficits
• radiculopathy and spinal claudication symptoms, all caused by degenerative changes in the lumbar spine, which were resistant to conservative pain therapy and / or physiotherapy

Exclusion Criteria

• previous surgeries in the abdominal Region
• previous fusion surgery in the lumbar spine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Homologous bone	Homologous Bone	The participants were treated with anterior lumbar interbody fusion (ALIF) with homologous bone
NanoBone	NanoBone	The participants were treated with anterior lumbar interbody fusion (ALIF) with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2)

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	12 months after surgery	Postoperative disability as measured by the Oswestry Disability Index (ODI)

Secondary Outcome Measures

Name	Time	Method
Fusion rate	12 months after surgery	Postoperative radiographic Fusion rate