RecruitingNot ApplicableNCT05856370

The Ailliance Post-Market Clinical Study

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

Sponsor

Medtronic Spinal and Biologics

Enrollment

1,000 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The Ailliance study is a large post-market clinical study collecting real-world safety and performance data on a range of Medtronic cranial and spinal technology devices — including products used in brain and spine surgery such as implants, fixation systems, and navigation tools. Post-market studies are required by regulatory authorities to confirm that devices approved for use continue to perform as expected in everyday clinical practice across diverse patient populations. Eligible participants are adults (18+, or minimum legal age per local regulations) who are scheduled to receive or have received a qualifying Medtronic cranial or spinal device as part of their standard care, and are willing to complete follow-up assessments. People enrolled in other trials that might interfere, those expected to miss follow-up visits, or vulnerable individuals at the time of consent are excluded. Participants are enrolled at the time of their procedure and followed up at defined intervals to report device performance, complications, and patient-reported outcomes. No experimental treatment is given — participants simply allow their clinical data to be collected. This matters because it provides the ongoing evidence base needed for device regulatory compliance and informs future improvements in neurosurgical and spinal surgical implants.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFollow-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

Locations(26)

University of Arizona

Tucson, Arizona, United States

OrthoArkansas

Little Rock, Arkansas, United States

University of California Davis Medical Center

Sacramento, California, United States

University of California, San Francisco (UCSF)

San Francisco, California, United States

Indiana University School of Medicine

Bloomington, Indiana, United States

Indiana Spine Group

Carmel, Indiana, United States

The Orthopaedic Research Foundation (OrthoIndy)

Indianapolis, Indiana, United States

Norton Leatherman Spine Specialists

Louisville, Kentucky, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Michigan Orthopaedic & Spine Surgeons

Rochester Hills, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

University at Buffalo

Buffalo, New York, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital University Orthopedic

Providence, Rhode Island, United States

Tennessee Orthopaedic Alliance

Nashville, Tennessee, United States

American Neurospine Institute, PLLC

Frisco, Texas, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Virginia Spine Institute

Reston, Virginia, United States

Centre Hospitalier Universitaire Dijon Bourgogne

Dijon, Bourgogne-Franche-Comté, France

Hôpital Roger Salengro

Lille, France

Centro Hospitalar Universitário São João

Porto, Portugal

Hospital Vall D'Hebron

Barcelona, Spain

Kings College Hospital NHS Foundation Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05856370

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