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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03331159

Enrollment

Registered

2017-11-06

Start date

2012-07-01

Completion date

2015-10-31

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fusion of Spine, Lumbar Region

Keywords

Lumbar Fusion, Hydroxyapatite

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.

Interventions

DEVICENanoBone

Cage was filled with nanocrystalline hydroxyapatite embedded in a silica gel matrix

DEVICEHomologous Bone

Cage was filled with homologous bone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Oswestry Disability Index (ODI)	12 months after surgery	Postoperative disability as measured by the Oswestry Disability Index (ODI)

Secondary

Measure	Time frame	Description
Fusion rate	12 months after surgery	Postoperative radiographic Fusion rate

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026