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

Study Overview
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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.

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

Conditions
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Fusion of Spine, Lumbar Region

Intervention / Treatment
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* Device: NanoBone
* Device: Homologous Bone


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NanoBone<br>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<br>* Cage was filled with nanocrystalline hydroxyapatite embedded in a silica gel matrix<br>|
| Active Comparator: Homologous bone<br>The participants were treated with anterior lumbar interbody fusion (ALIF) with homologous bone | Device: Homologous Bone<br>* Cage was filled with homologous bone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | Postoperative disability as measured by the Oswestry Disability Index (ODI) | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion rate | Postoperative radiographic Fusion rate | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Fusion, Hydroxyapatite