This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems that require post market clinical follow up (PMCF). The primary study hypothesis for each system is that the mean change in NDI (cervical) or ODI (lumbar) from baseline to Month 12 \< -10, that is, the mean improvement exceeds 10 points. In supporting analysis, the same hypotheses will be tested for mean change from baseline to 24 months to demonstrate durability of effectiveness.
Study Type
OBSERVATIONAL
Enrollment
28
This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing certain Stryker Interbody Systems.
Spine Institute of Louisiana Foundation, Inc.
Shreveport, Louisiana, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Spine Clinic of Oklahoma City
Oklahoma City, Oklahoma, United States
Inova Neurosciences Research
Falls Church, Virginia, United States
Mean Oswestry Disability Index Change
Oswestry Disability Index (ODI) (lumbar) improvement from baseline to 12 months. Scale of Oswestry Disability Index from 0-50, 0 meaning no disability.
Time frame: 12 Months
Mean Neck Disability Index Change
Neck Disability Index (NDI) (cervical) improvement from baseline to 12 months. Scale of Neck Disability Index from 0-50, 0 meaning no disability.
Time frame: 12 Months
Mean Oswestry Disability Index Change
Oswestry Disability Index (ODI) (lumbar) change from baseline to 24 months. Scale of Oswestry Disability Index from 0-50, 0 meaning no disability.
Time frame: 24 Months
Mean Neck Disability Index Change
Neck Disability Index (NDI) (cervical) change from baseline to 24 months. Scale of Neck Disability Index from 0-50, 0 meaning no disability.
Time frame: 24 months
Safety Events
The following safety events will be collected through 24 months, including the following: (MedDRA will be used to define these events) * Serious adverse events * Device-related adverse events * Procedure-related adverse events * Operative site adverse events * Secondary spine surgeries (secondary interventions) * Adverse event that negatively impacts the primary endpoint
Time frame: 24 months
Fusion Status
Fusion will be derived from a logical analysis of three component factors: angular motion, translational motion, and bridging bone. Each treated level must be considered fused in order for the subject to be considered a radiographic success.
Time frame: 3, 6, 12 and 24 months
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Angular Motion
Angular Motion will be measured from lateral flexion-extension radiographs. Angular motion, also known as rotation, is defined as the change in angle between the adjacent endplates of the motion segment. Angular Motion will be reported in units of degrees
Time frame: 3, 6, 12 and 24 months
Translational Motion
Translational Motion will be measured from lateral flexion-extension radiographs Translational motion is defined as the displacement of the posterior-inferior corner of the superior vertebra in a direction defined parallel to the superior endplate of the inferior vertebra. Translational Motion - Cervical will be reported in units of millimeters and percentage (%) of the anteroposterior (AP) length of the superior endplate of the inferior vertebra.
Time frame: 3, 6, 12 and 24 months
Bridging Bone
Interbody Bridging Bone will be graded in accordance with the following definitions: 1. Absent: No evidence of continuous bridging bone from endplate to endplate. 2. Present: Presence of continuous bridging bone from endplate to endplate.
Time frame: 3, 6, 12 and 24 months
Disc Height
Disc Height will be calculated from neutral lateral radiographs. Disc Height will be reported in units of millimeters and percentage (%) of the AP length of the superior endplate of the inferior vertebra. Average Disc Height
Time frame: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
Device Migration
Migration will be assessed relative to the Week 2 time point or earliest available post-operative visit. Migration will be measured in millimeters.
Time frame: 6 weeks, 3, 6, 12 and 24 months
Subsidence
Subsidence will be assessed relative to the Week 2 time point or earliest available post-operative visit, Subsidence will be measured in millimeters.
Time frame: 6 weeks, 3, 6, 12 and 24 months
Adjacent Segment Degeneration
Adjacent Segment Degeneration will be assessed at the adjacent levels using the Kellgren-Lawrence Osteoarthritis Grade.
Time frame: 2 and 6 weeks, 3, 6, 12 and 24 months
Device and Supplemental Fixation Breakage
Device and Supplemental Fixation Breakage will be assessed via all available x-ray images
Time frame: 2 and 6 weeks, 3, 6, 12 and 24 months
Visual Analogue Scale Pain Severity
A Visual Analogue Scale patient questionnaire will be used to define the pain in the specific regions (cervical or lumbar) in the course of the study. 0 will be defined as "no pain" and 10 the Worst Possible Pain.
Time frame: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
EQ-5D
The EQ-5D questionnaire is a standard generic patient questionnaire used to determine the health-related quality of life changes in the course of the study.
Time frame: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months
Prolo Scale
The Prolo Scale is a 10-point scale consisting of only two questions evaluating the functional and economic status of the patient in the course of this study.
Time frame: PreOp, 2 and 6 weeks, 3, 6, 12 and 24 months