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Study of Bioactive Glass-ceramic Intervertebral Spacer (Bonglass-SS) in Posterior Lumbar Interbody Fusion

This study is currently recruiting participants.
Verified September 2011 by BioAlpha Inc.
Sponsor:
Information provided by (Responsible Party):
BioAlpha Inc.
ClinicalTrials.gov Identifier:
NCT01439464
First received: September 22, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

The goal of this study is to compare Bonglass-SS with titanum cage.


Condition Intervention
Degenerative Disk Disease
 Device: 4 CIS one-touch titanium cage
Device: Bonglass-SS SSLPB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BioAlpha Inc.:

Primary Outcome Measures:
  • Radiographic assessments of fusion and instability at 12 months after surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CT assessments of fusion at 12 months after surgery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 86
Study Start Date: October 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control device Device: 4 CIS one-touch titanium cage
4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd)
Experimental: Investigational device Device: Bonglass-SS SSLPB
Bonglass-SS SSLPB(BioAlpha Inc.)

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439464

Contacts
Contact: JunHyuk Seo, Ph.D. 82-31-746-5208 ext 317 seoscy@daewoong.co.kr

Locations
Korea, Republic of
Dongguk University Medical Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of
Contact: KiHyoung Koo, M.D.,Ph.D.            
Seoul National University Bundang Hospital Recruiting
Sungnam-Si, Gyeonggi-Do, Korea, Republic of
Contact: KunWoo Park, M.D.,Ph.D.            
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: BongSoon Chang, M.D.,Ph.D.            
Seoul National University Seoul Metropolitan Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: JaeHyup Lee            
Sponsors and Collaborators
BioAlpha Inc.
Investigators
Principal Investigator: JaeHyup Lee, M.D.,Ph.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: BioAlpha Inc.
ClinicalTrials.gov Identifier: NCT01439464     History of Changes
Other Study ID Numbers: BA04-CP01
Study First Received: September 22, 2011
Last Updated: September 22, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 22, 2013