The Ailliance Post-Market Clinical Study for Spinal Conditions
This study is looking at the performance and safety of Medtronic devices used for cranial (head) and spinal conditions like spinal deformity, degenerative disorders, fusion failure, trauma, or tumors. You might be eligible if you are 18 or older and are planning to receive treatment with a Medtronic Cranial and Spinal Technology (CST) device. The study will track how well the surgery works (surgical success), if spinal fusion is successful, and how well the surgical tools perform. This information will be collected from your surgery up to 24 months afterward, as part of your routine medical care.
- Study design
- This is an interventional study planning to enroll 1000 participants. It aims to collect data on Medtronic devices used for cranial and spinal conditions.
- What's involved
- You would have follow-up assessments from before your surgery up to 24 months afterward. These assessments are part of your routine clinical care.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 24 months after their surgery to assess device performance and safety.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Ailliance Post-Market Clinical Study
At a glance
Conditions
Where it's being run
29 sites across 23 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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