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

Primary

• 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

  Time frame: 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.

  Time frame: 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.

  Time frame: 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.

  Time frame: 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

  Time frame: 12 months

• Stabilization (for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware)

  * 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)).

  Time frame: 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

  Time frame: 12 months