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 Sex
- 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
OrthoArkansas
Little Rock 4119403, Arkansas 4099753 72204
Little Rock 4119403, Arkansas 4099753 72204
University of California Davis Medical Center
Sacramento 5389489, California 5332921 95816
Sacramento 5389489, California 5332921 95816
University of California, San Francisco (UCSF)
San Francisco 5391959, California 5332921 94143
San Francisco 5391959, California 5332921 94143
Indiana University School of Medicine
Bloomington 4254679, Indiana 4921868 47401
Bloomington 4254679, Indiana 4921868 47401
Indiana Spine Group
Carmel 4255466, Indiana 4921868 46032
Carmel 4255466, Indiana 4921868 46032
The Orthopaedic Research Foundation (OrthoIndy)
Indianapolis 4259418, Indiana 4921868 46278
Indianapolis 4259418, Indiana 4921868 46278
Norton Leatherman Spine Specialists
Louisville 4299276, Kentucky 6254925 40202
Louisville 4299276, Kentucky 6254925 40202
University of Maryland Medical Center
Baltimore 4347778, Maryland 4361885 21201
Baltimore 4347778, Maryland 4361885 21201
Michigan Orthopaedic & Spine Surgeons
Rochester Hills 5007402, Michigan 5001836 48307
Rochester Hills 5007402, Michigan 5001836 48307
University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55454
Minneapolis 5037649, Minnesota 5037779 55454
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110-1010
St Louis 4407066, Missouri 4398678 63110-1010
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
The Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
University of Pittsburgh Medical Center UPMC Presbyterian
Pittsburgh 5206379, Pennsylvania 6254927 15213
Pittsburgh 5206379, Pennsylvania 6254927 15213
Rhode Island Hospital University Orthopedic
Providence 5224151, Rhode Island 5224323 02914
Providence 5224151, Rhode Island 5224323 02914
Tennessee Orthopaedic Alliance
Nashville 4644585, Tennessee 4662168 37209
Nashville 4644585, Tennessee 4662168 37209
American Neurospine Institute, PLLC
Frisco 4692559, Texas 4736286 75033
Frisco 4692559, Texas 4736286 75033
University of Virginia Health System
Charlottesville 4752031, Virginia 6254928 22903
Charlottesville 4752031, Virginia 6254928 22903
Virginia Spine Institute
Reston 4781530, Virginia 6254928 20191
Reston 4781530, Virginia 6254928 20191
More Details
- NCT ID
- NCT05856370
- Status
- Recruiting
- Sponsor
- Medtronic Spinal and Biologics