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

Johann Wolfgang Goethe University Hospital

Status: Completed

Conditions: Fusion of Spine, Lumbar Region

Treatments: Device: Homologous Bone; Device: NanoBone

Study type: Interventional

Funder types: Other

Identifiers

NCT03331159

NanoBone - ALIF

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

NanoBone

Experimental group

Description:

The participants were treated with anterior lumbar interbody fusion (ALIF) with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2)

Treatment:

Device: NanoBone

Homologous bone

Active Comparator group

Description:

The participants were treated with anterior lumbar interbody fusion (ALIF) with homologous bone

Treatment:

Device: Homologous Bone