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A Follow-up Study to Evaluate the Efficacy and Safety of Novomax in Posterior Lumbar Interbody Fusion

NCT03532945 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-05-22

No results posted yet for this study

Summary

This is a long-term follow-up study for more than 3 years to evaluate the efficacy and safety of bioactive glass-ceramic intervertebral spacer (Novomax) in posterior lumbar interbody fusion.

Conditions

  • Degenerative Lumbar Spinal Stenosis

Interventions

DEVICE

Bioactive Glass-Ceramic Spacer

DEVICE

Titanium cage

Sponsors & Collaborators

  • BioAlpha Inc.

    lead INDUSTRY

Principal Investigators

  • Bong-Soon Chang, MD. PhD. · Seoul National University Hospital

  • Ki Hyoung Koo, MD. PhD. · DongGuk University

  • Ho-Joong Kim, MD. PhD. · Seoul National University Bundang Hospital

  • Jae Hyup Lee, MD. PhD. · SMG-SNU Boramae Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-28
Primary Completion
2013-09-13
Completion
2016-04-07

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03532945 on ClinicalTrials.gov