The Ailliance Post-Market Clinical Study

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

Official Title
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The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction

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

Intervention / Treatment
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* Device: Follow-up schedule: pre-operative baseline to index surgery
* Device: Follow-up schedule: pre-operative baseline to discharge
* Device: Follow-up schedule: pre-operative baseline up to 24-months post-procedure


Participation Criteria
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Eligibility Criteria
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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). Subject who is, or is expected to be, inaccessible for all required follow-up visits. Subject with exclusion criteria required by local law. Subject is considered vulnerable at the time of obtaining consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Receiving eligible Medtronic Powered Systems, Instruments, and Imaging device(s)<br> | Device: Follow-up schedule: pre-operative baseline to index surgery<br>* Follow-up assessments will be required (therefore interventional) from pre-operative baseline to index surgery for those receiving eligible Medtronic Powered Systems, Instruments, and Imaging device(s)<br>|
| Other: Receiving eligible Advanced Energy device(s)<br> | Device: Follow-up schedule: pre-operative baseline to discharge<br>* Follow-up assessments will be required (therefore interventional) from pre-operative baseline to index surgery for those receiving eligible Advanced Energy device(s)<br>|
| Other: Receiving eligible device(s) from all other product groups<br>Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s) | Device: Follow-up schedule: pre-operative baseline up to 24-months post-procedure<br>* Follow-up assessments will be required (therefore interventional) from pre-operative baseline to index surgery for those receiving eligible Medtronic Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used) | Defined by amount of: 1) blood loss (mL) during surgery and/or 2) total operation time and/or 3) length of stay in the hospital (measured from surgery completion to discharge), and/or 4) investigator opinion on whether the device(s) directly assisted in the completion of surgery | Up to 24 months | 
| Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used) | Fusion success at 12-months, as assessed via radiographic evidence. | 12 months | 
| Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used) | Surgical performance, as defined as the rate at which the device directly assisted in the completion of surgery in the investigator's opinion. | Index Surgery | 
| Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used) | Robotics: Planned number of screws prior to index surgery compared to number of screws device assisted with placement during surgery. Navigation: Whether or not device was utilized for validation of screw placement during surgery. | Up to 24 months | 
| Deformity correction (for any Medtronic eligible market-released Spinal Tethers device(s) used) | Defined by the change of Cobb angle at 12-month | 12 months and up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards | The secondary endpoint is defined as the rate of occurrence for device-related adverse events | Up to 24 months | 
| Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Other Spinal Hardware, Rods and Screws] | Stabilization is the radiographic verification of no noticeable hardware and/or implant loosening, the presence of the hardware in the appropriate position without cage subsidence and/or implant loosening, and noticeable stable alignment of the spine post-surgery. Since all products are market-released, assessment for stabilization will be completed by the investigator. Stabilization will be assessed by the collection of radiographic evidence (X-Ray(s) and CT-scan(s)). [For Other Spinal Hardware device(s) used]: when radiographic fusion is not evident or no fusion is noted, stabilization will be assessed as a secondary endpoint | Up to 12 months | 
| Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws] | Deformity correction is defined by the change of Cobb angle at the 12-month postoperative visit compared to baseline. Assessment(s) for deformity correction will be completed by the investigator. The investigator will determine whether the subject meets requirements of deformity correction based on the comparison of the Cobb angle measurements at all postoperative visits, when compared to the subject's baseline assessments. Cobb angle measurements will be provided through collection of radiographic evidence (X-Ray(s) and CT-scan(s)) and assessed by the investigator. | Up to 12 months |