The Ailliance Post-Market Clinical Study

Launched by MEDTRONIC SPINAL AND BIOLOGICS · May 9, 2023

Keywords

ClinConnect Summary

The Ailliance Post-Market Clinical Study is designed to gather important information about the safety and effectiveness of certain Medtronic devices used for treating various spinal conditions, such as spinal deformities, degeneration, failures, trauma, and tumors. This study is not testing a new treatment but is observing the performance of devices that are already available in the market. If you decide to participate, you'll be followed up for up to 24 months after your treatment to help researchers understand how these devices work in a real-world setting.

To be eligible for this study, you need to be at least 18 years old and planning to receive a Medtronic Cranial and Spinal Technology device. You will also need to agree to complete all necessary check-ups and assessments. It’s important to note that if you are currently involved in another clinical trial, or if you may not be able to attend follow-up visits, you might not qualify for this study. Overall, this trial aims to ensure that these devices continue to provide safe and effective care for patients like you.

Gender

ALL

Eligibility criteria

• 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.