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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by BioAlpha Inc..
Recruitment status was  Recruiting
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 30, 2014