Study of Bioactive Glass-ceramic Intervertebral Spacer (Bonglass-SS) in Posterior Lumbar Interbody Fusion
NCT ID: NCT01439464
Last Updated: 2011-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
86 participants
INTERVENTIONAL
2010-10-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control device
4 CIS one-touch titanium cage
4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd)
Investigational device
Bonglass-SS SSLPB
Bonglass-SS SSLPB(BioAlpha Inc.)
Interventions
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4 CIS one-touch titanium cage
4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd)
Bonglass-SS SSLPB
Bonglass-SS SSLPB(BioAlpha Inc.)
Eligibility Criteria
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Inclusion Criteria
* A subject who provided written informed consent to participate in this study
Exclusion Criteria
* Women who are pregnant or plan to be pregnant within 3 years
* Patient with malignant tumor
30 Years
80 Years
ALL
No
Sponsors
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BioAlpha Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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JaeHyup Lee, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Dongguk University Medical Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Sungnam-Si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul National University Seoul Metropolitan Boramae Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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KiHyoung Koo, M.D.,Ph.D.
Role: primary
KunWoo Park, M.D.,Ph.D.
Role: primary
BongSoon Chang, M.D.,Ph.D.
Role: primary
JaeHyup Lee
Role: primary
Other Identifiers
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BA04-CP01
Identifier Type: -
Identifier Source: org_study_id