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

BioAlpha

Status: Unknown

Conditions: Degenerative Disk Disease

Treatments: Device: Bonglass-SS SSLPB; Device: 4 CIS one-touch titanium cage

Study type: Interventional

Funder types: Industry

Identifiers

NCT01439464

BA04-CP01

Details and patient eligibility

About

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

Enrollment: 86 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Control device

Active Comparator group

Treatment:

Device: 4 CIS one-touch titanium cage

Investigational device

Experimental group

Treatment:

Device: Bonglass-SS SSLPB