Collecting data on Medtronic spinal devices after surgery
The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction
This study is trying to see how well Medtronic spinal devices work and how safe they are for people after their surgery over the next two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medtronic Spinal and Biologics Industry-sponsored |
| Locations | 26 sites (Tucson, Arizona and 25 other locations) |
| Trial ID | NCT05856370 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to gather performance and safety data for Medtronic devices used in cranial and spinal procedures. Participants will be enrolled and monitored postoperatively for up to 24 months to assess the effectiveness and safety of these devices in routine clinical care. The study will follow a structured follow-up schedule, ensuring comprehensive data collection aligned with standard practices.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled to receive a Medtronic cranial or spinal device.
Not a fit: Patients currently enrolled in other concurrent trials that may affect the results of this study will not benefit from participation.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of Medtronic spinal devices' safety and effectiveness, leading to improved patient outcomes.
How similar studies have performed: Other studies involving post-market surveillance of medical devices have shown success in providing valuable safety and performance data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Tucson, Arizona and 25 other locations
- University of Arizona — Tucson, Arizona, United States (Recruiting)
- OrthoArkansas — Little Rock, Arkansas, United States (Recruiting)
- University of California Davis Medical Center — Sacramento, California, United States (Recruiting)
- University of California, San Francisco (UCSF) — San Francisco, California, United States (Recruiting)
- Indiana University School of Medicine — Bloomington, Indiana, United States (Recruiting)
- Indiana Spine Group — Carmel, Indiana, United States (Recruiting)
- The Orthopaedic Research Foundation (OrthoIndy) — Indianapolis, Indiana, United States (Recruiting)
- Norton Leatherman Spine Specialists — Louisville, Kentucky, United States (Recruiting)
- University of Maryland Medical Center — Baltimore, Maryland, United States (Recruiting)
- Michigan Orthopaedic & Spine Surgeons — Rochester Hills, Michigan, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- University at Buffalo — Buffalo, New York, United States (Recruiting)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
- University of Pittsburgh Medical Center UPMC Presbyterian — Pittsburgh, Pennsylvania, United States (Recruiting)
- Rhode Island Hospital University Orthopedic — Providence, Rhode Island, United States (Recruiting)
- Tennessee Orthopaedic Alliance — Nashville, Tennessee, United States (Recruiting)
- American Neurospine Institute, PLLC — Frisco, Texas, United States (Recruiting)
- University of Virginia Health System — Charlottesville, Virginia, United States (Recruiting)
- Virginia Spine Institute — Reston, Virginia, United States (Recruiting)
- Centre Hospitalier Universitaire Dijon Bourgogne — Dijon, Bourgogne-Franche-Comté, France (Recruiting)
- Hôpital Roger Salengro — Lille, France (Recruiting)
- Centro Hospitalar Universitário São João — Porto, Portugal (Recruiting)
- Hospital Vall D'Hebron — Barcelona, Spain (Recruiting)
- Kings College Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Lauren Oien
- Email: lauren.k.oien@medtronic.com
- Phone: +17635268124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.