This is a multicenter, prospective, retrospective, Post Market Clinical Follow-up (PMCF) study in subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared Instructions for Use (IFU).
Stryker Spine has a broad portfolio of spinal devices used to stabilize the spine. This PMCF study is designed to collect data on the performance and safety of the devices over their lifetime of 24 months post-implantation. Four protocols have been designed to aid in this process, a master and three sub-protocols. The sub-protocols are based on body region and indication: * S-S-102-A Cervical: Interbody Devices (IBDs), Vertebral Body Replacement Devices (VBRs), Internal Fixation Devices, and Vitoss * S-S-102-B Thoracolumbar: IBDs, VBRs, Internal Fixation Devices, and Vitoss * S-S-102-C Adult Spinal Deformities: IBDs, Internal Fixation Devices, and Vitoss Each of the sub-protocols has its own specific performance endpoint and hypothesis, radiographical data assessments, and SAPs. Safety data will be collected throughout the study.
Study Type
OBSERVATIONAL
Enrollment
5,222
Cervical Spinal Fusion
Thoracic / Lumbar Spinal Fusion
Spinal Deformities Correction
S-S-102-A
Mean change in the subject's Neck Disability Index (NDI) score.
Time frame: Baseline through 24-months post-op.
S-S-102-B
Mean change in the subject's Oswestry Disability Index (ODI) score.
Time frame: Baseline through 24-months post-op.
S-S-102-C
Mean change in the subject's Scoliosis Research Society-22 revised (SRS-22r).
Time frame: Baseline through 24-months post-op.
S-S-102-A
The incidence of the following safety events: * Serious Adverse Events (AEs) * Device-related AEs * Procedure-related AEs * Operative AEs * Secondary spine surgeries
Time frame: Surgery through 24-months post-op.
S-S-102-B
The incidence of the following safety events: * Serious Adverse Events (AEs) * Device-related AEs * Procedure-related AEs * Operative AEs * Secondary spine surgeries
Time frame: Surgery through 24-months post-op.
S-S-102-C
The incidence of the following safety events: * Serious Adverse Events (AEs) * Device-related AEs * Procedure-related AEs * Operative AEs * Secondary spine surgeries
Time frame: Surgery through 24-months post-op.
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