Purpose The primary purpose of this study is to prospectively compare clinical and radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.
Following surgery study subjects will be evaluated at the following intervals: 3 (+/- 2 weeks), 6 (+/- 1 month), 12 (+/- 2 months), 24 (+/- 2 months) months.
Study Type
OBSERVATIONAL
Enrollment
240
Lumbar or cervical fusion
Boulder Neurosurgical Associates
Boulder, Colorado, United States
Pain Intensity Scores
Improvement in the Neck/Arm or Low Back/Leg Visual Analog pain Scale (VAS) scores. A 30% reduction in pain intensity will be considered to be a successful response to treatment.
Time frame: 24 (+/- 2) months
Clinical and Radiographic Outcomes
* Assessment of Neck or Lower Back Disability Scores * Assessment of SF-36 Health Survey * Assessment of restoration of vertebral height, sagittal alignment, and graft subsidence * Assessment of fusion rates
Time frame: 3 (+/-2) weeks and 24 (+/- 2) months
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