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

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

BioAlpha Inc.

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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