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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Transforaminal Lumbar Interbody fusion (TLIF)
Transforaminal Lumbar Interbody Fusion (TLIF)
Medical University of South Carolina
Charleston, South Carolina, United States
RECRUITINGfusion rates
Assessment of the fusion rates as demonstrated by radiographic evidence.
Time frame: 12 months
Visual Analog Scale (VAS)
Visual Analog Scale pre-op compared to VAS score at 2-4 weeks, 6 months and at 1 year
Time frame: up to 12 months
Oswestry Disability Score (ODI)
Oswestry Low Back Pain Disability Questionaire
Time frame: 12 months
SF-36
Rand 36-item Health Survey (version 1.0)
Time frame: 12 months
Maintenance of disk height
comparison of disk height pre-op versus at 12 months
Time frame: 12 months
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