The Ailliance Post-Market Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2031-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Deformity Spinal Degenerative Disorder Spinal Fusion Failure Spinal Trauma Spinal Tumor Case

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Receiving eligible Medtronic device(s) from all product groups

Powered Systems, Instruments, and Imaging device(s), Advanced Energy device(s), Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)

Group Type OTHER

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

Intervention Type DEVICE

Follow-up assessments will be required (therefore interventional) from pre-operative baseline to 24 months post index surgery

Interventions

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

Follow-up assessments will be required (therefore interventional) from pre-operative baseline to 24 months post index surgery

Intervention Type DEVICE

Eligibility Criteria

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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.
4. Subject is considered vulnerable at the time of obtaining consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No