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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
rhNELL-1/DBX
Monash Medical Center
Clayton, Victoria, Australia
RECRUITINGSt Vincent Melbourne
Fitzroy, Australia
RECRUITINGSt George Hospital
Kogarah, Australia
RECRUITINGFusion
Defined by an independent (blinded to treatment) radiological assessment as less than five degrees angular vertebral motion, less than three millimeters of translational movement and evidence of bridging bone between the involved vertebral endplates based on x-rays at 12 months after surgery
Time frame: 12 months
Removal, revision, or supplemental fixation
Whether there was removal, revision or supplemental fixation of the graft material that required reoperation at the index level during the follow-up period of the study
Time frame: 12 months
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