The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction
Medtronic Spinal and Biologics
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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. Exclusion Criteria: 1. Subject is currently enrolled or plans to enroll in concurrent…
Interventions
- DeviceFollow-up schedule: pre-operative baseline up to 24-months post-procedure
Follow-up assessments will be required (therefore interventional) from pre-operative baseline to 24 months post index surgery
Locations (24)
- University of ArizonaTucson, Arizona
- OrthoArkansasLittle Rock, Arkansas
- University of California Davis Medical CenterSacramento, California
- University of California, San Francisco (UCSF)San Francisco, California
- Indiana University School of MedicineBloomington, Indiana
- Indiana Spine GroupCarmel, Indiana