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

Primary Purpose

Degenerative Disk Disease

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

4 CIS one-touch titanium cage

Bonglass-SS SSLPB

About this trial

This is an interventional treatment trial for Degenerative Disk Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dongguk University Medical CenterRecruiting
Seoul National University Bundang HospitalRecruiting
Seoul National University HospitalRecruiting
Seoul National University Seoul Metropolitan Boramae Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control device

Investigational device

Arm Description

Outcomes

Primary Outcome Measures

Radiographic assessments of fusion and instability at 12 months after surgery

Secondary Outcome Measures

CT assessments of fusion at 12 months after surgery

Full Information

NCT ID

NCT01439464

First Posted

September 22, 2011

Last Updated

September 22, 2011

Sponsor

BioAlpha Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01439464

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BioAlpha Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Degenerative Disk Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control device

Arm Type

Active Comparator

Arm Title

Investigational device

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

4 CIS one-touch titanium cage

Intervention Description

4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd)

Intervention Type

Device

Intervention Name(s)

Bonglass-SS SSLPB

Intervention Description

Bonglass-SS SSLPB(BioAlpha Inc.)

Primary Outcome Measure Information:

Title

Radiographic assessments of fusion and instability at 12 months after surgery

Time Frame

12 months

Secondary Outcome Measure Information:

Title

CT assessments of fusion at 12 months after surgery

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

JunHyuk Seo, Ph.D.

Phone

82-31-746-5208

Ext

317

seoscy@daewoong.co.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JaeHyup Lee, M.D.,Ph.D.

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dongguk University Medical Center

City

Goyang-si

State/Province

Gyeonggi-do

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

KiHyoung Koo, M.D.,Ph.D.

Facility Name

Seoul National University Bundang Hospital

City

Sungnam-Si

State/Province

Gyeonggi-Do

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

KunWoo Park, M.D.,Ph.D.

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

BongSoon Chang, M.D.,Ph.D.

Facility Name

Seoul National University Seoul Metropolitan Boramae Medical Center

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

JaeHyup Lee

12. IPD Sharing Statement

Learn more about this trial

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

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