The Ailliance Post-Market Clinical Study

Last updated: March 27, 2025
Sponsor: Medtronic Spinal and Biologics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Stenosis

Spinal Cord Malignancy

Spinal Cord Disorders

Treatment

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

Follow-up schedule: pre-operative baseline to index surgery

Follow-up schedule: pre-operative baseline to discharge

Clinical Study ID

NCT05856370
MDT22045CSTAIL
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject provides written informed consent per institution and/or geographicalrequirements.

  2. Subject is intended to receive or be treated with an eligible Medtronic Cranial andSpinal Technology (CST) device(s) (see product appendices), used alone or incombination, for a cranial and/or spinal indication(s).

  3. Subject is at least 18 years of age or minimum legal age as required by localregulations.

  4. Subject agrees to complete all required assessments per the Schedule of Events.

Exclusion

Exclusion Criteria:

  1. Subject is currently enrolled or plans to enroll in concurrent drug/device/biologictrial(s) that may confound this trial's results per investigator assessment (i.e. norequired intervention that could affect interpretation of all-around device safetyand or performance).

  2. Subject who is, or is expected to be, inaccessible for all required follow-upvisits.

  3. Subject with exclusion criteria required by local law.

  4. Subject is considered vulnerable at the time of obtaining consent.

Study Design

Total Participants: 1000
Treatment Group(s): 3
Primary Treatment: Follow-up schedule: pre-operative baseline up to 24-months post-procedure
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
May 31, 2031

Connect with a study center

  • University of California Davis Medical Center

    Sacramento, California 95816
    United States

    Active - Recruiting

  • University of California, San Francisco (UCSF)

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Indiana University School of Medicine

    Bloomington, Indiana 47401
    United States

    Active - Recruiting

  • Indiana Spine Group

    Carmel, Indiana 46032
    United States

    Active - Recruiting

  • The Orthopaedic Research Foundation (OrthoIndy)

    Indianapolis, Indiana 46278
    United States

    Active - Recruiting

  • Norton Leatherman Spine Specialists

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Michigan Orthopaedic & Spine Surgeons

    Rochester Hills, Michigan 48307
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55454
    United States

    Active - Recruiting

  • University at Buffalo

    Buffalo, New York 14221
    United States

    Active - Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center UPMC Presbyterian

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Rhode Island Hospital University Orthopedic

    Providence, Rhode Island 02914
    United States

    Active - Recruiting

  • Tennessee Orthopaedic Alliance

    Nashville, Tennessee 37209
    United States

    Active - Recruiting

  • American Neurospine Institute, PLLC

    Frisco, Texas 75033
    United States

    Active - Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Virginia Spine Institute

    Reston, Virginia 20191
    United States

    Active - Recruiting

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