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the Clinical Study of Novosis in Posterolateral Fusion

This study is not yet open for participant recruitment.
Verified January 2013 by BioAlpha Inc.
Sponsor:
Information provided by (Responsible Party):
BioAlpha Inc.
ClinicalTrials.gov Identifier:
NCT01764906
First received: January 7, 2013
Last updated: January 8, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the efficacay and safety of Novosis in posterolateral fusion


Condition Intervention
Posterolateral Fusion
 Device: Novosis
Procedure: Iliac crest bone graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Clinical Study to Evaluate the Efficacy and Safety of Novosis in Posterolateral Fusion

Resource links provided by NLM:

MedlinePlus related topics: Bone Grafts
U.S. FDA Resources

Further study details as provided by BioAlpha Inc.:

Primary Outcome Measures:
  • Fusion grade by CT assessments after surgery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fusion grade by Radiographic assessments after surgery [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Novosis
bongros/BMP-2
 Device: Novosis
Active Comparator: Iliac crest bone graft
Iliac crest bone graft
 Procedure: Iliac crest bone graft

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18~80 aged patients needed single-level posterolateral 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 study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764906

Contacts
Contact: Jun-Hyuk Seo seoscy@daewoong.co.kr

Locations
Korea, Republic of
SMG-SNU Boramae Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: JaeHyup Lee            
Sponsors and Collaborators
BioAlpha Inc.
  More Information

No publications provided

Responsible Party: BioAlpha Inc.
ClinicalTrials.gov Identifier: NCT01764906     History of Changes
Other Study ID Numbers: BA06-CP01
Study First Received: January 7, 2013
Last Updated: January 8, 2013
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on June 17, 2013