The Ailliance Post-Market Clinical Study
- Conditions
- Spinal TraumaSpinal DeformitySpinal Degenerative DisorderSpinal Fusion FailureSpinal Tumor Case
- Registration Number
- NCT05856370
- Lead Sponsor
- Medtronic Spinal and Biologics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used) Discharge (from Index Surgery completion to 14 days post-operatively) 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
Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used) 12 months 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.
Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used) Index Surgery 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.Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used) 24 months 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.
Deformity correction (for any Medtronic eligible market-released Spinal Tethers device(s) used) 12 months Defined by the change of Cobb angle at 12-month
Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware] Up to 12 months * 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)).Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Spinal Tethers] 12 months * 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.
- Secondary Outcome Measures
Name Time Method Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards 24 months The secondary endpoint is defined as the rate of occurrence for device-related adverse events
Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Rods and Screws] Up to 12 months * 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)).Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws] 12 months * 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.
Trial Locations
- Locations (19)
University of Arizona
🇺🇸Tucson, Arizona, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
University of California, San Francisco (UCSF)
🇺🇸San Francisco, California, United States
Indiana University School of Medicine
🇺🇸Bloomington, Indiana, United States
Indiana Spine Group
🇺🇸Carmel, Indiana, United States
The Orthopaedic Research Foundation (OrthoIndy)
🇺🇸Indianapolis, Indiana, United States
Norton Leatherman Spine Specialists
🇺🇸Louisville, Kentucky, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Michigan Orthopaedic & Spine Surgeons
🇺🇸Rochester Hills, Michigan, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University at Buffalo
🇺🇸Buffalo, New York, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Pittsburgh Medical Center UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
Rhode Island Hospital University Orthopedic
🇺🇸Providence, Rhode Island, United States
Tennessee Orthopaedic Alliance
🇺🇸Nashville, Tennessee, United States
American Neurospine Institute, PLLC
🇺🇸Frisco, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Virginia Spine Institute
🇺🇸Reston, Virginia, United States