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Recruiting NCT05856370

The Ailliance Post-Market Clinical Study

No phase Interventional Spinal Deformity Spinal Degenerative Disorder Spinal Fusion Failure Spinal Trauma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Follow-up schedule: pre-operative baseline up to 24-months post-procedure.
Who it may be relevant to
Registry conditions: Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, France, Germany, Portugal, Spain +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Follow-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

Primary outcome measures

  • Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used) [Time frame: Discharge (from Index Surgery completion to 14 days post-operatively)]
  • Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used) [Time frame: 12 months]
  • Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used) [Time frame: Index Surgery]
  • Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used) [Time frame: 24 months]
  • Pain Resolution (for select Medtronic eligible market-released Other Spinal Hardware device(s) used) [Time frame: 12 months]
  • Stabilization (for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware) [Time frame: Up to 12 months]
  • Deformity Correction (for specified Medtronic eligible market-released device(s) used from the following product groups: Spinal Tethers) [Time frame: 12 months]
Secondary outcome measures (3)
  • Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards [Time frame: 24 months]
  • Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Rods and Screws] [Time frame: Up to 12 months]
  • Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws] [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Subject provides written informed consent per institution and/or geographical requirements.
  • 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).
  • Subject is at least 18 years of age or minimum legal age as required by local regulations.
  • 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).
  • Subject who is, or is expected to be, inaccessible for all required follow-up visits.
  • Subject with exclusion criteria required by local law.
  • Subject is considered vulnerable at the time of obtaining consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 23 centers
  • University of Arizona — Tucson
  • OrthoArkansas — Little Rock
  • University of California Davis Medical Center — Sacramento
  • University of California, San Francisco (UCSF) — San Francisco
  • Indiana University School of Medicine — Bloomington
  • Indiana Spine Group — Carmel
  • The Orthopaedic Research Foundation (OrthoIndy) — Indianapolis
  • Norton Leatherman Spine Specialists — Louisville
  • … and 15 more centers
France · 2 centers
  • Centre Hospitalier Universitaire Dijon Bourgogne — Dijon
  • Hôpital Roger Salengro — Lille
Germany · 1 center
  • Charité - Universitätsmedizin Berlin — Berlin
Portugal · 1 center
  • Centro Hospitalar Universitário São João — Porto
Spain · 1 center
  • Hospital Vall D'Hebron — Barcelona
United Kingdom · 1 center
  • Kings College Hospital NHS Foundation Trust — London

Identifiers

NCT: NCT05856370 · MDT22045CSTAIL

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗