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| Name | Class |
|---|---|
| Medtronic Cardiac Rhythm and Heart Failure | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiving eligible Medtronic device(s) from all product groups | Other | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow-up schedule: pre-operative baseline up to 24-months post-procedure | Device | Follow-up assessments will be required (therefore interventional) from pre-operative baseline to 24 months post index surgery |
| 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 | 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) | Fusion success at 12-months is determined through evaluation of radiographic evidence (X-ray and/or CT scan) by the investigator by: (1) Confirming the presence of bone bridging, and (2) if using the Brantigan & Steffee's Classification scale: a score D and/or E are determined. | 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. If O-Arm used: whether O-Arm was utilized for validation of implant placement during the surgery. | 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. | 24 months |
| Pain Resolution (for select Medtronic eligible market-released Other Spinal Hardware device(s) used) | Resolution of pain at 12-months when compared to baseline Pain reported by the subject using the Neck Disability Index (NDI) questionnaire |
| 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 | 24 months |
| Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Rods and Screws] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Oien | Contact | +17635268124 | lauren.k.oien@medtronic.com | |
| Erwan Diarra | Contact | +33 7 86 55 72 84 | erwan.diarra@medtronic.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Tucson | Arizona | 85721 | United States |
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| 12 months |
| Stabilization (for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware) |
| Up to 12 months |
| Deformity Correction (for specified Medtronic eligible market-released device(s) used from the following product groups: Spinal Tethers) | Defined by the change of Cobb angle at 12-month | 12 months |
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| Up to 12 months |
| Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws] |
| 12 months |
| OrthoArkansas | Recruiting | Little Rock | Arkansas | 72204 | United States |
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| University of California Davis Medical Center | Recruiting | Sacramento | California | 95816 | United States |
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| University of California, San Francisco (UCSF) | Recruiting | San Francisco | California | 94143 | United States |
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| Indiana University School of Medicine | Recruiting | Bloomington | Indiana | 47401 | United States |
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| Indiana Spine Group | Recruiting | Carmel | Indiana | 46032 | United States |
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| The Orthopaedic Research Foundation (OrthoIndy) | Recruiting | Indianapolis | Indiana | 46278 | United States |
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| Norton Leatherman Spine Specialists | Recruiting | Louisville | Kentucky | 40202 | United States |
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| University of Maryland Medical Center | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Michigan Orthopaedic & Spine Surgeons | Recruiting | Rochester Hills | Michigan | 48307 | United States |
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| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55454 | United States |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110-1010 | United States |
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| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
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| Rutgers University Department of Neurosurgery | Recruiting | New Brunswick | New Jersey | 08901-2065 | United States |
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| University at Buffalo | Recruiting | Buffalo | New York | 14221 | United States |
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| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
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| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
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| University of Pittsburgh Medical Center UPMC Presbyterian | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| Rhode Island Hospital University Orthopedic | Recruiting | Providence | Rhode Island | 02914 | United States |
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| Tennessee Orthopaedic Alliance | Recruiting | Nashville | Tennessee | 37209 | United States |
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| American Neurospine Institute, PLLC | Recruiting | Frisco | Texas | 75033 | United States |
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| University of Virginia Health System | Recruiting | Charlottesville | Virginia | 22903 | United States |
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| Virginia Spine Institute | Recruiting | Reston | Virginia | 20191 | United States |
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| Centre Hospitalier Universitaire Dijon Bourgogne | Recruiting | Dijon | Bourgogne-Franche-Comté | 21079 | France |
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| Hôpital Roger Salengro | Recruiting | Lille | 59037 | France |
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| Centro Hospitalar Universitário São João | Recruiting | Porto | 4200-319 | Portugal |
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| Hospital Vall D'Hebron | Recruiting | Barcelona | 08035 | Spain |
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| Kings College Hospital NHS Foundation Trust | Recruiting | London | SE5 9RS | United Kingdom |
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