The Ailliance Post-Market Clinical Study

Recruiting now · Not applicable

Conditions studied: Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma, Spinal Tumor Case

In brief

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.

Key facts

Study ID

NCT05856370

Run by

Medtronic Spinal and Biologics

People needed

1000

Starts

2023-05-01

Expected to finish

2031-05-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 with exclusion criteria required by local law.
• Subject is considered vulnerable at the time of obtaining consent.

Where it is running

• University of Arizona — Tucson, Arizona, United States (enrolling)
• OrthoArkansas — Little Rock, Arkansas, United States (enrolling)
• University of California Davis Medical Center — Sacramento, California, United States (enrolling)
• University of California, San Francisco (UCSF) — San Francisco, California, United States (enrolling)
• Indiana University School of Medicine — Bloomington, Indiana, United States (enrolling)
• Indiana Spine Group — Carmel, Indiana, United States (enrolling)
• The Orthopaedic Research Foundation (OrthoIndy) — Indianapolis, Indiana, United States (enrolling)
• Norton Leatherman Spine Specialists — Louisville, Kentucky, United States (enrolling)
• University of Maryland Medical Center — Baltimore, Maryland, United States (enrolling)
• Michigan Orthopaedic & Spine Surgeons — Rochester Hills, Michigan, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Rutgers University Department of Neurosurgery — New Brunswick, New Jersey, United States (enrolling)
• University at Buffalo — Buffalo, New York, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
• University of Pittsburgh Medical Center UPMC Presbyterian — Pittsburgh, Pennsylvania, United States (enrolling)
• Rhode Island Hospital University Orthopedic — Providence, Rhode Island, United States (enrolling)
• Tennessee Orthopaedic Alliance — Nashville, Tennessee, United States (enrolling)
• American Neurospine Institute, PLLC — Frisco, Texas, United States (enrolling)
• University of Virginia Health System — Charlottesville, Virginia, United States (enrolling)
• Virginia Spine Institute — Reston, Virginia, United States (enrolling)
• Centre Hospitalier Universitaire Dijon Bourgogne — Dijon, Bourgogne-Franche-Comté, France (enrolling)
• Hôpital Roger Salengro — Lille, France (enrolling)

Full record on ClinicalTrials.gov

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