The Clinical Study of Novosis in Posterolateral Fusion

NCT ID: NCT01764906

Last Updated: 2015-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-03-31

Brief Summary

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

Detailed Description

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Conditions

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Posterolateral Fusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Novosis

Bongros/rhBMP-2

Group Type EXPERIMENTAL

Novosis

Intervention Type DEVICE

Iliac crest bone graft

Iliac crest bone graft

Group Type ACTIVE_COMPARATOR

Iliac crest bone graft

Intervention Type PROCEDURE

Interventions

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Novosis

Intervention Type DEVICE

Iliac crest bone graft

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioAlpha Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BA06-CP01

Identifier Type: -

Identifier Source: org_study_id

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