NCT03331159

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

October 29, 2017

Last Update Submit

October 31, 2017

Conditions

Fusion of Spine, Lumbar Region

Keywords

Lumbar FusionHydroxyapatite

Outcome Measures

Primary Outcomes (1)

  • Oswestry Disability Index (ODI)

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

    12 months after surgery

Secondary Outcomes (1)

  • Fusion rate

    12 months after surgery

Study Arms (2)

NanoBone

EXPERIMENTAL

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

Homologous bone

ACTIVE COMPARATOR

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

Device: Homologous Bone

Interventions

NanoBoneDEVICE

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

NanoBone
Homologous BoneDEVICE

Cage was filled with homologous bone

Homologous bone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • previous surgeries in the abdominal Region
  • previous fusion surgery in the lumbar spine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 29, 2017

First Posted

November 6, 2017

Study Start

July 1, 2012

Primary Completion

October 31, 2013

Study Completion

October 31, 2015

Last Updated

November 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share