Low Back Pain Clinical Trial
Official title:
A Prospective Study of the InterFuse T(tm)
The purpose of this post-approval study is to demonstrate that the InterFuse T modular lumbar interbody device is at least equal in safety and efficacy to other (standard of care) TLIF devices.
The primary objective of this post-market study is to collect data to asses the long term
outcome of the InterFuse T (tm) device in [patients undergoing interbody fusion.
The primary endpoints of the investigation will include assessment of the maintenance of
disc height and fusion rates demonstrated by radiographic evidence based on plain
radiographs. Fusion is defined as a bone bridging across the disc space at the level of the
InterFuse T implant. Length of stay, implant migration, implant subsidence, re-operation
rate and opioid use will be recorded. It is anticipated that outcomes with the InterFuse T
Interbody Fusion Device will be comparable to or better than the historical published
results for other non-modular TLIF devices and to the control device used concurrently in
the study
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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