A Multi-center, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody Fusion
Phase 3
- Conditions
- Transforaminal Lumbar Interbody Fusion
- Registration Number
- NCT02504242
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 128
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks) at 48 weeks after surgery
- Secondary Outcome Measures
Name Time Method