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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02504242
Recruitment Status : Unknown
Verified July 2015 by BioAlpha Inc..
Recruitment status was:  Enrolling by invitation
First Posted : July 21, 2015
Last Update Posted : September 1, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Transforaminal Lumbar Interbody Fusion Device: Inject BMP Procedure: Locally Harvested Bone Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2015
Estimated Primary Completion Date : April 2017

Arm Intervention/treatment
Experimental: Inject BMP
ExcelOS Inject / rhBMP-2
Device: Inject BMP
Active Comparator: Locally Harvested Bone
Locally Harvested Bone
Procedure: Locally Harvested Bone

Primary Outcome Measures :
  1. Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks) [ Time Frame: at 48 weeks after surgery ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: BioAlpha Inc. Identifier: NCT02504242     History of Changes
Other Study ID Numbers: ExcelOs14-02
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: July 2015