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

BioAlpha

Status and phase: Unknown; Phase 3

Conditions: Transforaminal Lumbar Interbody Fusion

Treatments: Procedure: Locally Harvested Bone; Device: Inject BMP

Study type: Interventional

Funder types: Industry

Identifiers

NCT02504242

ExcelOs14-02

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Inject BMP

Experimental group

Description:

ExcelOS Inject / rhBMP-2

Treatment:

Device: Inject BMP

Locally Harvested Bone

Active Comparator group

Description:

Locally Harvested Bone

Treatment:

Procedure: Locally Harvested Bone