Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
NCT ID: NCT03810573
Last Updated: 2024-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-03-01
2026-06-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NB1-1.5
NB1 low dose
NB1
rhNELL-1/DBX
NB1-2.0
NB1 high dose
NB1
rhNELL-1/DBX
Autograft
Autograft
No interventions assigned to this group
Interventions
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NB1
rhNELL-1/DBX
Eligibility Criteria
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Inclusion Criteria
* Up to Grade I spondylolisthesis
* Eligible to undergo a single vertebral level spine fusion (L2 to S1)
Exclusion Criteria
* Grade II or greater spondylolisthesis
* Systemic or local infection at the site of surgery
17 Years
70 Years
ALL
No
Sponsors
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Bone Biologics Corp
INDUSTRY
Responsible Party
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Principal Investigators
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Tony Goldschlager, MD
Role: PRINCIPAL_INVESTIGATOR
Monash Health
Locations
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Monash Medical Center
Clayton, Victoria, Australia
St Vincent Melbourne
Fitzroy, , Australia
St George Hospital
Kogarah, , Australia
Countries
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Central Contacts
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Facility Contacts
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Tony Goldschlager, MD
Role: primary
Terence Tan
Role: primary
Ashish Diwan
Role: primary
Other Identifiers
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NB1-100
Identifier Type: -
Identifier Source: org_study_id
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