Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuos or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental posterolateral fusion as directed by physician, but must comply with FDA approved/cleared indication for use and labeling.
The purpose of this study is to compare clinical and radiographic outcomes in patients undergoing transforaminal lumbar interbody fusion (minimally invasive or open) with either Virtuos bone graft or autograft/allograft bone graft. Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuos or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental posterolateral fusion as directed by physician, but must comply with FDA approved/cleared indication for use and labeling.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Use of autograft or Virtuos Lyograft as an adjunct to spinal fusion in TLIF.
Central CT Neurosurgery & Spine
New Britain, Connecticut, United States
Michigan Brain and Spine
Royal Oak, Michigan, United States
University of Texas South Western
Dallas, Texas, United States
Successful Fusion
Fusion status at Twelve months postoperative
Time frame: Twelve months
Clinical Outcomes
Patient Reported Outcomes (PROM): Disability and Pain
Time frame: Twelve months
Safety Profile
Incidence of Adverse Events and Serious Adverse Events through Twelve and Twenty-four months.
Time frame: Twelve and Twenty-four months
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