The Ailliance Post-Market Clinical Study
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Receiving eligible Medtronic device(s) from all product groups |
Powered Systems, Instruments, and Imaging device(s), Advanced Energy device(s), Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s) |
|
Recruiting Locations
University of California Davis Medical Center
Sacramento, California 95816
Sacramento, California 95816
University of California, San Francisco (UCSF)
San Francisco, California 94143
San Francisco, California 94143
Indiana University School of Medicine
Bloomington, Indiana 47401
Bloomington, Indiana 47401
The Orthopaedic Research Foundation (OrthoIndy)
Indianapolis, Indiana 46278
Indianapolis, Indiana 46278
Norton Leatherman Spine Specialists
Louisville, Kentucky 40202
Louisville, Kentucky 40202
University of Maryland Medical Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
Michigan Orthopaedic & Spine Surgeons
Rochester Hills, Michigan 48307
Rochester Hills, Michigan 48307
Washington University School of Medicine
Saint Louis, Missouri 63110-1010
Saint Louis, Missouri 63110-1010
Washington University School of Medicine
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
Columbus, Ohio 43210
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Rhode Island Hospital University Orthopedic
Providence, Rhode Island 02914
Providence, Rhode Island 02914
American Neurospine Institute, PLLC
Frisco, Texas 75033
Frisco, Texas 75033
University of Virginia Health System
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
More Details
- NCT ID
- NCT05856370
- Status
- Recruiting
- Sponsor
- Medtronic Spinal and Biologics