Post-market follow-up on Stryker spinal devices used in cervical and thoracolumbar fusion for degenerative spine conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter study combining prospective and retrospective data collection to follow patients who have had or will have spinal fusion surgery using Stryker devices. The study uses four protocols (one master and three sub-protocols) focusing on cervical, thoracolumbar, and adult spinal deformities, with predefined performance endpoints and radiographic assessments. Safety data are collected throughout the 24-month post-implant period to evaluate long-term outcomes. Principal sites include Mayo Clinic Florida, MaineHealth Neurosurgery and Spine, and Michigan Orthopaedic Surgeons, with lead sponsorship by VB Spine, LLC.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic Florida
  Jacksonville, Florida, United States Recruiting
• MaineHealth Neurosurgery and Spine
  Scarborough, Maine, United States Recruiting
• Michigan Orthopaedic Surgeons
  Southfield, Michigan, United States Recruiting
• Cleveland Clinc
  Cleveland, Ohio, United States Recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting
• Texas Spine & Scoliosis
  Austin, Texas, United States Recruiting

Study contacts

• Principal investigator: Jad G. Khalil, MD — Michigan Orthopaedic Surgeons
• Study coordinator: Mary Majer
• Email: mary.majer@vbspineco.com
• Phone: 866-526-4171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.