Collecting data on Medtronic spinal devices after surgery

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 clinical study aims to gather performance and safety data for Medtronic devices used in cranial and spinal procedures. Participants will be enrolled and monitored postoperatively for up to 24 months to assess the effectiveness and safety of these devices in routine clinical care. The study will follow a structured follow-up schedule, ensuring comprehensive data collection aligned with standard practices.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject provides written informed consent per institution and/or geographical requirements.
2. Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s).
3. Subject is at least 18 years of age or minimum legal age as required by local regulations.
4. Subject agrees to complete all required assessments per the Schedule of Events.

Exclusion Criteria:

1. Subject is currently enrolled or plans to enroll in concurrent drug/device/biologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance).
2. Subject who is, or is expected to be, inaccessible for all required follow-up visits.
3. Subject with exclusion criteria required by local law.
4. Subject is considered vulnerable at the time of obtaining consent.

Where it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting
• OrthoArkansas
  Little Rock, Arkansas, United States Recruiting
• University of California Davis Medical Center
  Sacramento, California, United States Recruiting
• University of California, San Francisco (UCSF)
  San Francisco, California, United States Recruiting
• Indiana University School of Medicine
  Bloomington, Indiana, United States Recruiting
• Indiana Spine Group
  Carmel, Indiana, United States Recruiting

Study contacts

• Study coordinator: Lauren Oien
• Email: lauren.k.oien@medtronic.com
• Phone: +17635268124

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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.