The purpose of this study is to collect on-label safety and efficacy data where InQu Bone Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF). It is expected that this study will contribute to the compilation of clinical data required to demonstrate the ability of InQu to promote safe, effective and timely spine fusion in patients who undergo PLIF or TLIF surgery. The results of this study will lead to further analysis (i.e. comparison to historical data of other marketed bone graft products, as well as, to local bone alone).
The purpose of this study is to collect on-label safety and efficacy data where InQu Bone Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF) at multiple clinical sites. Adverse events, time to fusion and Patient Reported Outcomes(PROs) will be recorded through 12 months follow-up.
Study Type
OBSERVATIONAL
Enrollment
130
University of Southern Califirnia
Los Angeles, California, United States
RECRUITINGWilliam Beaumont Hospital
Royal Oak, Michigan, United States
NOT_YET_RECRUITINGPost-operative bone fusion as measured by lumbar CT scan Bone fusion
Time frame: 12 months
Adverse Events
Time frame: Continual post treatment
Need for subsequent surgical intervention at target and/or adjacent level
Time frame: Continual post treatment
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