Study of Bioactive Glass-ceramic Intervertebral Spacer (B... | NCT01439464

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

NCT01439464

Sponsor

BioAlpha Inc.

Status

Unknown status

Last Update Posted

Sep 23, 2011Estimated

Enrollment

86Estimated

Phase

Not Applicable

Conditions

Degenerative Disk Disease

Interventions

4 CIS one-touch titanium cage
Bonglass-SS SSLPB

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Mar 2013Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Sep 22, 2011

First Submission Date that Met QC Criteria

Sep 22, 2011

First Posted Date

Sep 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2011

Last Update Posted Date

Sep 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

86Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control device	Active Comparator		Device: 4 CIS one-touch titanium cage
Investigational device	Experimental		Device: Bonglass-SS SSLPB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
4 CIS one-touch titanium cage	Device	4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd)	Control device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiographic assessments of fusion and instability at 12 months after surgery		12 months

Secondary Outcomes

Measure	Description	Time Frame
CT assessments of fusion at 12 months after surgery		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
JunHyuk Seo, Ph.D.	Contact	82-31-746-5208	317	seoscy@daewoong.co.kr

Overall Officials

Name	Affiliation	Role
JaeHyup Lee, M.D.,Ph.D.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dongguk University Medical Center	Recruiting	Goyang-si	Gyeonggi-do		South Korea