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

Transforaminal Lumbar Interbody Fusion Clinical Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02504242
• Other study ID #: ExcelOs14-02
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: July 20, 2015
• Last updated: August 30, 2015
• Start date: April 2015

Study information

• Verified date: July 2015
• Source: BioAlpha Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 128
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Transforaminal Lumbar Interbody Fusion

Intervention

Device:
• Inject BMP

Procedure:
• Locally Harvested Bone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioAlpha Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks)		at 48 weeks after surgery	No