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

September 22, 2011 updated by: BioAlpha Inc.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • BongSoon Chang, M.D.,Ph.D.
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Seoul Metropolitan Boramae Medical Center
        • Contact:
          • JaeHyup Lee
    • Gyeonggi-Do
      • Sungnam-Si, Gyeonggi-Do, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • KunWoo Park, M.D.,Ph.D.
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • dongguk University Medical Center
        • Contact:
          • KiHyoung Koo, M.D.,Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control device
Device: 4 CIS one-touch titanium cage
4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd)
EXPERIMENTAL: Investigational device
Device: Bonglass-SS SSLPB
Bonglass-SS SSLPB(BioAlpha Inc.)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioAlpha Inc.

Investigators

  • Principal Investigator: JaeHyup Lee, M.D.,Ph.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ANTICIPATED)

March 1, 2013

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

September 22, 2011

First Submitted That Met QC Criteria

September 22, 2011

First Posted (ESTIMATE)

September 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 23, 2011

Last Update Submitted That Met QC Criteria

September 22, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA04-CP01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe