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NCT06226272Recruiting

Clinical Outcome Measure at Stryker Spine

VB Spine, LLC

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

Inclusion Criteria: • To be eligible to participate in the study, the potential subject must meet all inclusion criteria specific to the Stryker system being evaluated, please contact one of the participating investigators or see the device-specific cleared IFU, for further details. Exclusion Criteria: • The exclusion criteria are based on the contraindications as presented in the Stryker device cleared IFUs, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.

Interventions

DEVICE

Spinal Fusion

DEVICE

Spinal Fusion

DEVICE

Spinal Deformities Correction

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Conditions

Degenerative Disc DiseaseDegenerative Scoliosis

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