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NCT05856370NARecruiting

The Ailliance Post-Market Clinical Study

Medtronic Spinal and Biologics

Start Date

5/1/2023

Completion Date

5/1/2031

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

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Subject provides written informed consent per institution and/or geographical requirements. 2. 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). 3. Subject is at least 18 years of age or minimum legal age as required by local regulations. 4. Subject agrees to complete all required assessments per the Schedule of Events. Exclusion Criteria: 1. 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). 2. Subject who is, or is expected to be, inaccessible for all required follow-up visits. 3. Subject with exclusion criteria required by local law. 4. Subject is considered vulnerable at the time of obtaining consent.

Interventions

DEVICE

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

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Spinal DeformitySpinal Degenerative DisorderSpinal Fusion FailureSpinal TraumaSpinal Tumor Case

Locations

University of Arizona

Tucson, Arizona 85721

United States

OrthoArkansas

Little Rock, Arkansas 72204

United States

University of California Davis Medical Center

Sacramento, California 95816

United States

University of California, San Francisco (UCSF)

San Francisco, California 94143

United States

Indiana University School of Medicine

Bloomington, Indiana 47401

United States

Indiana Spine Group

Carmel, Indiana 46032

United States

The Orthopaedic Research Foundation (OrthoIndy)

Indianapolis, Indiana 46278

United States

Norton Leatherman Spine Specialists

Louisville, Kentucky 40202

United States

University of Maryland Medical Center

Baltimore, Maryland 21201

United States

Michigan Orthopaedic & Spine Surgeons

Rochester Hills, Michigan 48307

United States

University of Minnesota

Minneapolis, Minnesota 55454

United States

Washington University School of Medicine

St Louis, Missouri 63110-1010

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Rutgers University Department of Neurosurgery

New Brunswick, New Jersey 08901-2065

United States

University at Buffalo

Buffalo, New York 14221

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania 15213

United States

Rhode Island Hospital University Orthopedic

Providence, Rhode Island 02914

United States

Tennessee Orthopaedic Alliance

Nashville, Tennessee 37209

United States

American Neurospine Institute, PLLC

Frisco, Texas 75033

United States

University of Virginia Health System

Charlottesville, Virginia 22903

United States

Virginia Spine Institute

Reston, Virginia 20191

United States

Centre Hospitalier Universitaire Dijon Bourgogne

Dijon, Bourgogne-Franche-Comté 21079

France

Hôpital Roger Salengro

Lille, 59037

France

Centro Hospitalar Universitário São João

Porto, 4200-319

Portugal

Hospital Vall D'Hebron

Barcelona, 08035

Spain

Kings College Hospital NHS Foundation Trust

London, SE5 9RS

United Kingdom