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

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ClinicalTrials.gov 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

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
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.
ClinicalTrials.gov 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