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The Clinical Study of Novosis in Posterolateral Fusion

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.
ClinicalTrials.gov Identifier: NCT01764906
Recruitment Status : Unknown
Verified January 2013 by BioAlpha Inc..
Recruitment status was:  Enrolling by invitation
First Posted : January 10, 2013
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
BioAlpha Inc.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of Novosis in posterolateral fusion

Condition or disease Intervention/treatment
Posterolateral Fusion Device: Novosis Procedure: Iliac crest bone graft

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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
Study Start Date : March 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Novosis
Bongros/rhBMP-2
Device: Novosis
Active Comparator: Iliac crest bone graft
Iliac crest bone graft
Procedure: Iliac crest bone graft



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

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


Information from the National Library of Medicine

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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

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.

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