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

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ClinicalTrials.gov Identifier: NCT03331159
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Mohammad ARAB MOTLAGH, 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

Condition or disease Intervention/treatment Phase
Fusion of Spine, Lumbar Region Device: NanoBone Device: Homologous Bone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Fusion After Anterior Lumbar Interbody Fusion With a New Osteoinductive Bone Substitute Material: a First Randomized Clinical Trial
Actual Study Start Date : July 1, 2012
Actual Primary Completion Date : October 31, 2013
Actual Study Completion Date : October 31, 2015

Arm Intervention/treatment
Experimental: NanoBone
The participants were treated with anterior lumbar interbody fusion (ALIF) with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2)
Device: NanoBone
Cage was filled with nanocrystalline hydroxyapatite embedded in a silica gel matrix

Active Comparator: Homologous bone
The participants were treated with anterior lumbar interbody fusion (ALIF) with homologous bone
Device: Homologous Bone
Cage was filled with homologous bone




Primary Outcome Measures :
  1. Oswestry Disability Index (ODI) [ Time Frame: 12 months after surgery ]
    Postoperative disability as measured by the Oswestry Disability Index (ODI)


Secondary Outcome Measures :
  1. Fusion rate [ Time Frame: 12 months after surgery ]
    Postoperative radiographic Fusion rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Mohammad ARAB MOTLAGH, MD, PhD, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT03331159    
Other Study ID Numbers: NanoBone - ALIF
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohammad ARAB MOTLAGH, Johann Wolfgang Goethe University Hospital:
Lumbar Fusion
Hydroxyapatite