The Ailliance Post-Market Clinical Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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.
• Pain Resolution (for select Medtronic eligible market-released Other Spinal Hardware device(s) used) — 12 months
  Resolution of pain at 12-months when compared to baseline Pain reported by the subject using the Neck Disability Index (NDI) questionnaire
• 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
  Defined by the change of Cobb angle at 12-month

Trial sites (29)

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