NCT02504242
Unknown
Phase 3
A Multi-center, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody Fusion
BioAlpha Inc.0 sites128 target enrollmentApril 2015
ConditionsTransforaminal Lumbar Interbody Fusion
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Transforaminal Lumbar Interbody Fusion
- Sponsor
- BioAlpha Inc.
- Enrollment
- 128
- Primary Endpoint
- Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks)
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks)
Time Frame: at 48 weeks after surgery
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