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

NCT ID: NCT02504242

Last Updated: 2015-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30

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.

Conditions

Transforaminal Lumbar Interbody Fusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Inject BMP

ExcelOS Inject / rhBMP-2

Group Type: EXPERIMENTAL

Inject BMP

Intervention Type: DEVICE

Locally Harvested Bone

Locally Harvested Bone

Group Type: ACTIVE_COMPARATOR

Locally Harvested Bone

Intervention Type: PROCEDURE

Interventions

Inject BMP

Intervention Type: DEVICE

Locally Harvested Bone

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioAlpha Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ExcelOs14-02

Identifier Type: -

Identifier Source: org_study_id