Medtronic Device Follow-Up for Spinal Conditions

N/A

Recruiting

Research Sponsored by Medtronic Spinal and Biologics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months and up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial collects performance and safety data from people who already have Medtronic devices used for cranial and/or spinal conditions, monitored over 24 months.

Who is the study for?

This trial is for adults who need a Medtronic Cranial and Spinal Technology device for conditions like spinal tumors, scoliosis, or spinal trauma. Participants must give written consent, agree to follow-up assessments up to 24 months post-surgery, and not be in other trials that could affect results.

What is being tested?

The study is tracking the performance and safety of Medtronic devices used in surgeries for various cranial and spinal issues. Patients will have routine clinical care data collected from before surgery until up to two years after the procedure.

What are the potential side effects?

Since this trial involves post-market medical devices rather than drugs, specific side effects are not listed; however, typical risks may include infection at the surgery site, pain, swelling or complications related to spine surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months and up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months and up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Deformity correction (for any Medtronic eligible market-released Spinal Tethers device(s) used)

Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)

Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used)

+2 more

Secondary study objectives

Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws]

Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards

Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Other Spinal Hardware, Rods and Screws]