- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01764906
The Clinical Study of Novosis in Posterolateral Fusion
April 21, 2015 updated by: BioAlpha Inc.
The Clinical Study to Evaluate the Efficacy and Safety of Novosis in Posterolateral Fusion
The purpose of this study is to evaluate the efficacy and safety of Novosis in posterolateral fusion
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- SMG-SNU Boramae Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Novosis
Bongros/rhBMP-2
|
|
Active Comparator: Iliac crest bone graft
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fusion grade by CT assessments after surgery
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fusion grade by Radiographic assessments after surgery
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
March 1, 2016
Study Registration Dates
First Submitted
January 7, 2013
First Submitted That Met QC Criteria
January 8, 2013
First Posted (Estimate)
January 10, 2013
Study Record Updates
Last Update Posted (Estimate)
April 22, 2015
Last Update Submitted That Met QC Criteria
April 21, 2015
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- BA06-CP01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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