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

N/AUnknownNCT01439464

BioAlpha Inc.86 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Degenerative Disk Disease

Interventions

4 CIS one-touch titanium cageDEVICE

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

Bonglass-SS SSLPBDEVICE

Bonglass-SS SSLPB(BioAlpha Inc.)

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (4)

Dongguk University Medical Center

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Seoul National University Bundang Hospital

Sungnam-Si, Gyeonggi-do, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

Radiographic assessments of fusion and instability at 12 months after surgery

Time frame: 12 months

Secondary Outcomes

CT assessments of fusion at 12 months after surgery

Time frame: 12 months

Central Contacts

JunHyuk Seo, Ph.D.

CONTACT

82-31-746-5208 seoscy@daewoong.co.kr

Data from ClinicalTrials.gov

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