The Ailliance Post-Market Clinical Study

Medtronic

Status: Enrolling

Conditions: Spinal Trauma; Spinal Tumor Case; Spinal Deformity; Spinal Fusion Failure; Spinal Degenerative Disorder

Treatments: Device: Follow-up schedule: pre-operative baseline up to 24-months post-procedure; Device: Follow-up schedule: pre-operative baseline to discharge; Device: Follow-up schedule: pre-operative baseline to index surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT05856370

MDT22045CSTAIL

Details and patient eligibility

About

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 for up to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 3 patient groups

Receiving eligible Medtronic Powered Systems, Instruments, and Imaging device(s)

Other group

Treatment:

Device: Follow-up schedule: pre-operative baseline to index surgery

Receiving eligible Advanced Energy device(s)

Other group

Treatment:

Device: Follow-up schedule: pre-operative baseline to discharge

Receiving eligible device(s) from all other product groups

Other group

Description:

Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)

Treatment:

Device: Follow-up schedule: pre-operative baseline up to 24-months post-procedure