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Completed

NCT Number: NCT03331159

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

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

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Key information

Conditions

Fusion of Spine, Lumbar Region

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NanoBone

Device

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

Homologous Bone

Device

Cage was filled with homologous bone

Primary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: 12 months after surgery

    Postoperative disability as measured by the Oswestry Disability Index (ODI)

Secondary outcomes

  1. Fusion rate

    Time frame: 12 months after surgery

    Postoperative radiographic Fusion rate

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Nov 6, 2017
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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