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

Degenerative Disk Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01439464
• Other study ID #: BA04-CP01
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2011
• Last updated: September 22, 2011
• Start date: October 2010
• Est. completion date: June 2013

Study information

• Verified date: September 2011
• Source: BioAlpha Inc.
• Contact: JunHyuk Seo, Ph.D.
• Phone: 82-31-746-5208
• Email: seoscy[@]daewoong.co.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Disk Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• 4 CIS one-touch titanium cage
4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd)
• Bonglass-SS SSLPB
Bonglass-SS SSLPB(BioAlpha Inc.)

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Medical Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul National University Seoul Metropolitan Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Sungnam-Si	Gyeonggi-Do

Sponsors (1)

Lead Sponsor	Collaborator
BioAlpha Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic assessments of fusion and instability at 12 months after surgery		12 months	No
Secondary	CT assessments of fusion at 12 months after surgery		12 months	No