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

NCT ID: NCT03331159

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-01

Study Completion Date

2015-10-31

Brief Summary

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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

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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

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Fusion of Spine, Lumbar Region

Keywords

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Lumbar Fusion Hydroxyapatite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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NanoBone

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

Group Type EXPERIMENTAL

NanoBone

Intervention Type DEVICE

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

Homologous bone

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

Group Type ACTIVE_COMPARATOR

Homologous Bone

Intervention Type DEVICE

Cage was filled with homologous bone

Interventions

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NanoBone

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

Intervention Type DEVICE

Homologous Bone

Cage was filled with homologous bone

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mohammad ARAB MOTLAGH

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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NanoBone - ALIF

Identifier Type: -

Identifier Source: org_study_id