A Multi-center, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody Fusion

Phase 3

• Conditions: Transforaminal Lumbar Interbody Fusion
• Interventions: Device: Inject BMP; Procedure: Locally Harvested Bone

• Registration Number: NCT02504242
• Lead Sponsor: BioAlpha Inc.

Brief Summary

A Randomized, Subject-Assessor Blind, Multi-center, Comparative Clinical Trial to evaluate the efficacy and safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody Fusion.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Status Verified: 2015-07
• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-21
• Last Update Submitted: 2015-08-30
• Last Update Posted: 2015-09-01
• Primary Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

The subject needs the infusion between the first lumbar vertebrato and the first ilium from those who require posterior spinal instrumentation and interbody fusion for the following reasons,

• Spinal stenosis
• Spinal disc herniation requiring broad laminectomy
• Spondylolisthesis or spondylolysis
• Recurrent herniated disc

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
Inject BMP	Inject BMP	ExcelOS Inject / rhBMP-2
Locally Harvested Bone	Locally Harvested Bone	Locally Harvested Bone

Primary Outcome Measures

Name	Time	Method
Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks)	at 48 weeks after surgery