Clinical Outcome Measure at Stryker Spine
Start Date
1/28/2025
Completion Date
1/29/2032
Summary
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).
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Spinal Fusion
Spinal Fusion
Spinal Deformities Correction
Conditions
Locations
Mayo Clinic Florida
Jacksonville, Florida 32224
United States
MaineHealth Neurosurgery and Spine
Scarborough, Maine 04074
United States
Michigan Orthopaedic Surgeons
Southfield, Michigan 48033
United States
Cleveland Clinc
Cleveland, Ohio 44195
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Texas Spine & Scoliosis
Austin, Texas 78705
United States
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States