The Ailliance Post-Market Clinical Study

NCT05856370 | Recruiting FDA Device

• 1 other identifier: MDT22045CSTAIL
• Study Type: interventional
• Target: 1,000
• Locations: 4 countries
• Sites: 24

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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

  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.

  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.

  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.

  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

  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)).

  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

  12 months

Secondary Outcomes (3)

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

  24 months

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

  Up to 12 months

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

  12 months

Study Arms (1)

Receiving eligible Medtronic device(s) from all product groups

OTHER

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

Interventions

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

Receiving eligible Medtronic device(s) from all product groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 is considered vulnerable at the time of obtaining consent.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: collaborator
• Medtronic Spinal and Biologics: lead

Study Sites (24)

University of Arizona

Tucson, Arizona, 85721, United States

RECRUITING

OrthoArkansas

Little Rock, Arkansas, 72204, United States

RECRUITING

University of California Davis Medical Center

Sacramento, California, 95816, United States

RECRUITING

University of California, San Francisco (UCSF)

San Francisco, California, 94143, United States

RECRUITING

Indiana University School of Medicine

Bloomington, Indiana, 47401, United States

RECRUITING

Indiana Spine Group

Carmel, Indiana, 46032, United States

RECRUITING

The Orthopaedic Research Foundation (OrthoIndy)

Indianapolis, Indiana, 46278, United States

RECRUITING

Norton Leatherman Spine Specialists

Louisville, Kentucky, 40202, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Michigan Orthopaedic & Spine Surgeons

Rochester Hills, Michigan, 48307, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55454, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110-1010, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

University at Buffalo

Buffalo, New York, 14221, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Rhode Island Hospital University Orthopedic

Providence, Rhode Island, 02914, United States

RECRUITING

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37209, United States

RECRUITING

American Neurospine Institute, PLLC

Frisco, Texas, 75033, United States

RECRUITING

University of Virginia Health System

Charlottesville, Virginia, 22903, United States

RECRUITING

Virginia Spine Institute

Reston, Virginia, 20191, United States

RECRUITING

Hôpital Roger Salengro

Lille, 59037, France

RECRUITING

Hospital Vall D'Hebron

Barcelona, 08035, Spain

RECRUITING

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Central Study Contacts

Lauren Oien

CONTACT

+17635268124; lauren.k.oien@medtronic.com

Erwan Diarra

CONTACT

+33 7 86 55 72 84; erwan.diarra@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: May 12, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (1); US (21); GB (1); ES (1)