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 Maryland Medical Center
Baltimore, Maryland 21201
Baltimore, Maryland 21201
More Details
- Status
- Recruiting
- Sponsor
- Medtronic Spinal and Biologics