NCT05856370 · Medtronic Spinal and Biologics
The Ailliance Post-Market Clinical Study
What this study is about
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.
View original scientific description
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.
Interventions
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
Primary outcome measures
Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 12 months
Defined by the change of Cobb angle at 12-month
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Tucson, Arizona
- Little Rock, Arkansas
- Sacramento, California
- San Francisco, California
- Bloomington, Indiana
- Carmel, Indiana
- Indianapolis, Indiana
- Louisville, Kentucky
- Baltimore, Maryland
- Rochester Hills, Michigan
- Minneapolis, Minnesota
- St Louis, Missouri
And 10 more locations — see the full list below.
Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 17, 2026 · Source of record for eligibility and locations