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The Ailliance Post-Market Clinical Study

Sponsor: Medtronic Spinal and Biologics

NCT ID: NCT05856370

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Follow-up schedule: pre-operative baseline up to 24-months post-procedure (device)
How long the study runs
Study runs about 96 months (dates as stated)
About the drug or intervention
Follow-up schedule: pre-operative baseline up to 24-months post-procedure — device: Follow-up assessments will be required (therefore interventional) from pre-operative baseline to 24 months post index surgery
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by Medtronic Spinal and Biologics, looks at people treated with eligible Medtronic Cranial and Spinal Technology devices for conditions affecting the spine, such as spinal deformity, degenerative disorder, fusion failure, trauma or tumour. It is a post-market study, meaning it collects information after the devices are already in normal use.

Who can take part

  • You give written informed consent, following your hospital's and local rules.
  • You are due to be treated with an eligible Medtronic Cranial and Spinal Technology device, on its own or with others, for a condition of the skull or spine.
  • You are at least 18 years old, or the minimum legal age where you live.
  • You agree to complete all the required study assessments.

Who may not be able to

  • You are taking part, or plan to take part, in another trial of a drug, device or biological product that could affect this study's results, in the researcher's view.
  • You cannot, or are not expected to be able to, attend all the required follow-up visits.
  • You meet any exclusion set by local law.
  • You are considered vulnerable at the time of giving consent.

What taking part involves

  • • Not stated — ask the trial team.

Time commitment: Not stated — ask the trial team about number of visits, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,000
Started
2023-05-01
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for spinal deformity
  • • NA - 1,000 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with spinal deformity

Where?

  • • London - Kings College Hospital NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Spinal DeformitySpinal Degenerative DisorderSpinal Fusion FailureSpinal TraumaSpinal Tumor Case

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ by local regulations
  • ✓ assessments per the Schedule of Events

What the study is looking for

  • ✓Subject provides written agreement to take part per institution and/or geographical requirements.
  • ✓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.

Who cannot take part

  • ✗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.
See the full 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 Is This Study? (1 UK site)

Kings College Hospital NHS Foundation Trust

London SE5 9RS, United Kingdom

Recruiting
Site contact (verified)
Gordon Grahovac, MDPrincipal Investigator

How to Get in Touch

Lauren Oien

Sponsor contact

CONTACT

+17635268124 lauren.k.oien@medtronic.com

Erwan Diarra

Sponsor contact

CONTACT

+33 7 86 55 72 84 erwan.diarra@medtronic.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08