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

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

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

Study Overview

• Status: Completed
• Conditions: Fusion of Spine, Lumbar Region
• Intervention / Treatment: Device: NanoBone; Device: Homologous Bone

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Johann Wolfgang Goethe University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): October 31, 2013
• Study Completion (Actual): October 31, 2015

Study Registration Dates

• First Submitted: October 29, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Hydroxyapatite; Lumbar Fusion
• Other Study ID Numbers: NanoBone - ALIF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No