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Clinical Trials/NCT01439464
NCT01439464
Unknown
Not Applicable

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

BioAlpha Inc.4 sites in 1 country86 target enrollmentOctober 2010
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ConditionsDegenerative Disk Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Degenerative Disk Disease
Sponsor
BioAlpha Inc.
Enrollment
86
Locations
4
Primary Endpoint
Radiographic assessments of fusion and instability at 12 months after surgery
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
June 2013
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
BioAlpha Inc.
Responsible Party
Sponsor

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

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(12 months)

Study Sites (4)

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