An interventional study of Follow-up schedule: pre-operative baseline up to 24-months post-procedure in Spinal Deformity, Spinal Degenerative Disorder and Spinal Fusion Failure, sponsored by Medtronic Spinal and Biologics. Recruiting at 29 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Medtronic Spinal and Biologics (part of Medtronic) · Not applicable, Interventional, and Health services research
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.
Medtronic Spinal and Biologics is the lead sponsor of 57 studies on the registry; 3 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Device: 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
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
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
Time frame: 24 months
Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Rods and Screws]
* 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: Rods and Screws]
* 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.
Time frame: 12 months
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Started May 2023 (actual). Primary completion is estimated for May 2031, 96 months after the start.
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