Intervertebral Disc Degeneration Clinical Trial
Official title:
A Prospective Study of the Safety and Efficacy of InQu® Bone Graft Extender in Transforaminal and Posterior Lumbar Interbody Fusion Surgery
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.
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