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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01439464

Enrollment

Registered

2011-09-23

Start date

2010-10-31

Completion date

2013-06-30

Last updated

2011-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disk Disease

Brief summary

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

Interventions

DEVICE4 CIS one-touch titanium cage

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

DEVICEBonglass-SS SSLPB

Bonglass-SS SSLPB(BioAlpha Inc.)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
CT assessments of fusion at 12 months after surgery	12 months

Countries

South Korea

Contacts

Primary ContactJunHyuk Seo, Ph.D.

seoscy@daewoong.co.kr82-31-746-5208

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026