The Clinical Study of Novosis in Posterolateral Fusion

Not Applicable

• Conditions: Posterolateral Fusion
• Interventions: Procedure: Iliac crest bone graft; Device: Novosis

• Registration Number: NCT01764906
• Lead Sponsor: BioAlpha Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-10
• Study Start: 2013-03
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22
• Primary Completion: 2015-12
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iliac crest bone graft	Iliac crest bone graft	Iliac crest bone graft
Novosis	Novosis	Bongros/rhBMP-2

Primary Outcome Measures

Name	Time	Method
Fusion grade by CT assessments after surgery	24 weeks

Secondary Outcome Measures

Name	Time	Method
Fusion grade by Radiographic assessments after surgery	24 weeks

Trial Locations

Locations (1)

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of