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

Not Applicable

• Conditions: Degenerative Disk Disease
• Interventions: Device: 4 CIS one-touch titanium cage; Device: Bonglass-SS SSLPB

• Registration Number: NCT01439464
• Lead Sponsor: BioAlpha Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Status Verified: 2011-09
• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-09-22
• Last Update Submitted: 2011-09-22
• Study First Posted: 2011-09-23
• Last Update Posted: 2011-09-23
• Primary Completion: 2013-03
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control device	4 CIS one-touch titanium cage	-
Investigational device	Bonglass-SS SSLPB	-

Primary Outcome Measures

Name	Time	Method
Radiographic assessments of fusion and instability at 12 months after surgery	12 months

Secondary Outcome Measures

Name	Time	Method
CT assessments of fusion at 12 months after surgery	12 months

Trial Locations

Locations (4)

Seoul National University Seoul Metropolitan Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Dongguk University Medical Center; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Sungnam-Si, Gyeonggi-Do, Korea, Republic of