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Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

RecruitingNAAges 17 Years - 70 YearsAllBone Biologics Corp
NCT03810573 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The objective of this clinical study is to evaluate the safety and effectiveness of NB1 Bone Graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion. It is estimated that up to 30 participants will be enrolled in approximately 3 clinical sites. During baseline and follow-up assessments, patients will be asked to undergo x-rays and CT scans; adverse events and immunology will be collected, and; participants will be requested to complete participant questionnaires regarding quality of life, pain and function.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Documented diagnosis of degenerative disc disease * Up to Grade I spondylolisthesis * Eligible to undergo a single vertebral level spine fusion (L2 to S1) Exclusion Criteria: * Previous spinal instrumentation or previous interbody fusion procedure at the involved level * Grade II or greater spondylolisthesis * Systemic or local infection at the site of surgery
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What it tests

  • NB1
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Where

2 sites
Monash Medical Center
Clayton, Australia
St Vincent Melbourne
Fitzroy, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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