- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01439464
Study of Bioactive Glass-ceramic Intervertebral Spacer (Bonglass-SS) in Posterior Lumbar Interbody Fusion
September 22, 2011 updated by: BioAlpha Inc.
Clinical Efficacy and Safety of Bioactive Glass-ceramic Intervertebral Spacer (Bonglass-SS) in Posterior Lumbar Interbody Fusion and, Titanium Cage Controlled, 1-year, Single-Blind, Non-Inferiority Trial
The goal of this study is to compare Bonglass-SS with titanum cage.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: JunHyuk Seo, Ph.D.
- Phone Number: 317 82-31-746-5208
- Email: seoscy@daewoong.co.kr
Study Locations
-
-
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
-
Contact:
- BongSoon Chang, M.D.,Ph.D.
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Seoul Metropolitan Boramae Medical Center
-
Contact:
- JaeHyup Lee
-
-
Gyeonggi-Do
-
Sungnam-Si, Gyeonggi-Do, Korea, Republic of
- Recruiting
- Seoul National University Bundang Hospital
-
Contact:
- KunWoo Park, M.D.,Ph.D.
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republic of
- Recruiting
- Dongguk University Medical Center
-
Contact:
- KiHyoung Koo, M.D.,Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 30~80 aged patients needed single-level posterior Interbody fusion at L1~S1
- A subject who provided written informed consent to participate in this study
Exclusion Criteria:
- Patitents with BMD T-score < -3.0
- Women who are pregnant or plan to be pregnant within 3 years
- Patient with malignant tumor
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Control device
|
4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd)
|
EXPERIMENTAL: Investigational device
|
Bonglass-SS SSLPB(BioAlpha Inc.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Radiographic assessments of fusion and instability at 12 months after surgery
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CT assessments of fusion at 12 months after surgery
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: JaeHyup Lee, M.D.,Ph.D., Seoul National University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (ANTICIPATED)
March 1, 2013
Study Completion (ANTICIPATED)
June 1, 2013
Study Registration Dates
First Submitted
September 22, 2011
First Submitted That Met QC Criteria
September 22, 2011
First Posted (ESTIMATE)
September 23, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
September 23, 2011
Last Update Submitted That Met QC Criteria
September 22, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BA04-CP01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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