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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:
Information provided by (Responsible Party):
BioAlpha Inc.
ClinicalTrials.gov Identifier:
NCT01764906
First received: January 7, 2013
Last updated: April 21, 2015
Last verified: January 2013
  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: 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

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
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

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
Study First Received: January 7, 2013
Last Updated: April 21, 2015

ClinicalTrials.gov processed this record on July 21, 2017