RecruitingNot Applicable

The Ailliance Post-Market Clinical Study

United States, France, Portugal1,000 participantsStarted 2023-05-01

Plain-language summary

The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject provides written informed consent per institution and/or geographical requirements.
. 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).
. Subject is at least 18 years of age or minimum legal age as required by local regulations.
. Subject agrees to complete all required assessments per the Schedule of Events.

Exclusion criteria

. 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)

Timeframe: Discharge (from Index Surgery completion to 14 days post-operatively)

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

Timeframe: 12 months

Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)

Timeframe: Index Surgery

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

Timeframe: 24 months

Pain Resolution (for select Medtronic eligible market-released Other Spinal Hardware device(s) used)

Timeframe: 12 months

Stabilization (for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware)

Timeframe: Up to 12 months

Trial details

NCT IDNCT05856370

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-05

Contact for this trial

Lauren Oien

+17635268124 lauren.k.oien@medtronic.com

View on ClinicalTrials.gov More Spinal Deformity trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subject provides written informed consent per institution and/or geographical requirements.
. 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).
. Subject is at least 18 years of age or minimum legal age as required by local regulations.
. Subject agrees to complete all required assessments per the Schedule of Events.

Exclusion criteria

. 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).

What they're measuring

Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)

Timeframe: Discharge (from Index Surgery completion to 14 days post-operatively)

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

Timeframe: 12 months

Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)

Timeframe: Index Surgery

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

Timeframe: 24 months

Pain Resolution (for select Medtronic eligible market-released Other Spinal Hardware device(s) used)

Timeframe: 12 months

Stabilization (for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware)

Timeframe: Up to 12 months