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The Clinical Study of Novosis in Posterolateral Fusion

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
BioAlpha Inc. Identifier:
First received: January 7, 2013
Last updated: April 21, 2015
Last verified: January 2013
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
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

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: 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
Device: Novosis
Active Comparator: Iliac crest bone graft
Iliac crest bone graft
Procedure: Iliac crest bone graft


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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 identifier: NCT01764906

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

Responsible Party: BioAlpha Inc. Identifier: NCT01764906     History of Changes
Other Study ID Numbers: BA06-CP01 
Study First Received: January 7, 2013
Last Updated: April 21, 2015
Health Authority: Korea: Food and Drug Administration processed this record on January 17, 2017