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Recruiting Not applicable NCT03810573

Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis

No applicable phase (e.g. observational)
Conditions: Degenerative Disc Disease Spondylolisthesis

Sponsor: Bone Biologics Corp

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 1
Australia (1)
Monash Medical Center
Clayton , Victoria
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
17 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
01.03.2024
Completion date
01.06.2026
Registry ID
NCT03810573
Source
anzctr
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