the Clinical Study of Novosis in Posterolateral Fusion

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 29, 2014