The Ailliance Post-Market Clinical Study

Description

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

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Study Overview

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Study Details

Study overview

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.

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

The Ailliance Post-Market Clinical Study

Condition
Spinal Deformity
Intervention / Treatment

-

Contacts and Locations

Sacramento

University of California Davis Medical Center, Sacramento, California, United States, 95816

San Francisco

University of California, San Francisco (UCSF), San Francisco, California, United States, 94143

Bloomington

Indiana University School of Medicine, Bloomington, Indiana, United States, 47401

Carmel

Indiana Spine Group, Carmel, Indiana, United States, 46032

Indianapolis

The Orthopaedic Research Foundation (OrthoIndy), Indianapolis, Indiana, United States, 46278

Louisville

Norton Leatherman Spine Specialists, Louisville, Kentucky, United States, 40202

Rochester Hills

Michigan Orthopaedic & Spine Surgeons, Rochester Hills, Michigan, United States, 48307

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55454

Buffalo

University at Buffalo, Buffalo, New York, United States, 14221

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medtronic Spinal and Biologics,

Study Record Dates

2031-05