Collecting data on Medtronic spinal devices after surgery

The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction

Not applicable Interventional Medtronic Spinal and Biologics · NCT05856370

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

PhaseNot applicable
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorMedtronic Spinal and Biologics Industry-sponsored
Locations26 sites (Tucson, Arizona and 25 other locations)
Trial IDNCT05856370 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

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Spinal DeformitySpinal Degenerative DisorderSpinal Fusion FailureSpinal TraumaSpinal Tumor Case
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.