The Clinical Study of Novosis in Posterolateral Fusion

BioAlpha

Status: Unknown

Conditions: Posterolateral Fusion

Treatments: Device: Novosis; Procedure: Iliac crest bone graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT01764906

BA06-CP01

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Novosis

Experimental group

Description:

Bongros/rhBMP-2

Treatment:

Device: Novosis

Iliac crest bone graft

Active Comparator group

Description:

Iliac crest bone graft

Treatment:

Procedure: Iliac crest bone graft