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NCT Number: NCT05856370

The Ailliance Post-Market Clinical Study

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.

Recruiting

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Key information

Conditions

Spinal Deformity Spinal Degenerative Disorder Spinal Fusion Failure Spinal Trauma Spinal Tumor Case

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, Bourgogne-Franche-Comté, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Follow-up schedule: pre-operative baseline up to 24-months post-procedure

Device

Follow-up assessments will be required (therefore interventional) from pre-operative baseline to 24 months post index surgery

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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)).

  7. 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

Secondary outcomes

  1. Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards

    Time frame: 24 months

    The secondary endpoint is defined as the rate of occurrence for device-related adverse events

  2. Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Rods and Screws]

    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)).

  3. Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws]

    Time frame: 12 months

    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Erwan Diarra

CONTACT

[email protected]

+33 7 86 55 72 84

Lauren Oien

CONTACT

[email protected]

+17635268124

Sponsors and collaborators

Lead sponsor

Medtronic Spinal and Biologics

Industry

Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
May 12, 2023
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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