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The Clinical Study of Novosis in Posterolateral Fusion

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by BioAlpha Inc..
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01764906
First Posted: January 10, 2013
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
BioAlpha Inc.
  Purpose
The purpose of this study is to evaluate the efficacy 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Study to Evaluate the Efficacy and Safety of Novosis in Posterolateral Fusion

Further study details as provided by BioAlpha Inc.:

Primary Outcome Measures:
  • Fusion grade by CT assessments after surgery [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Fusion grade by Radiographic assessments after surgery [ Time Frame: 24 weeks ]

Estimated Enrollment: 90
Study Start Date: March 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Novosis
Bongros/rhBMP-2
Device: Novosis
Active Comparator: Iliac crest bone graft
Iliac crest bone graft
Procedure: Iliac crest bone graft

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  • Patients with BMD T-score < -3.0
  • Women who are pregnant or plan to be pregnant within study period
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01764906


Locations
Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
BioAlpha Inc.
  More Information

Responsible Party: BioAlpha Inc.
ClinicalTrials.gov Identifier: NCT01764906     History of Changes
Other Study ID Numbers: BA06-CP01
First Submitted: January 7, 2013
First Posted: January 10, 2013
Last Update Posted: April 22, 2015
Last Verified: January 2013