Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05856370

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

Led by Medtronic Spinal and Biologics · Updated on 2026-06-02

1000

Participants Needed

27

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Medtronic Spinal and Biologics

Lead Sponsor

M

Medtronic Cardiac Rhythm and Heart Failure

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are collecting performance and safety information for Medtronic devices that are already available on the market and used for cranial or spinal conditions. The study focuses on people who receive these devices for spinal deformities, degenerative disorders, fusion failure, trauma, or tumors. It aims to gather data that aligns with regular clinical care to better understand how these devices work in real-world settings. Participants will receive one or more eligible Medtronic Cranial and Spinal Technology devices, which may include powered systems, instruments, imaging devices, advanced energy devices, robotics and navigation tools, rods and screws, interbodies and biologics, spinal tethers, or other spinal hardware. The study involves follow-up assessments from before surgery through 24 months after the procedure to monitor device performance and surgical outcomes. During the study, participants will undergo various evaluations including surgical success within 14 days post-operation, fusion success at 12 months, device performance up to 24 months, pain resolution, stabilization, and deformity correction depending on the devices used. Follow-up visits include assessments consistent with routine care, and safety is monitored by tracking device-related adverse events over 24 months. The total participation duration is up to two years.

CONDITIONS

Brief Title

The Ailliance Post-Market Clinical Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 device(s) alone or in combination for cranial and/or spinal indications.
  • 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.
Not Eligible

You will not qualify if you...

  • Subject is currently enrolled or plans to enroll in concurrent drug/device/biologic trials that may affect this study's results.
  • Subject is, or is expected to be, inaccessible for all required follow-up visits.
  • Subject has exclusion criteria required by local law.
  • Subject is considered vulnerable at the time of obtaining consent.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Surgery and Immediate Post-operative Care

Duration - From surgery to 14 days post-operatively

Participants receive the Medtronic Cranial and Spinal Technology device(s) during the index surgery and are monitored through discharge up to 14 days post-operatively.

1 surgery visit and approximately 1 to 2 post-operative visits

Post-operative Follow-up

Duration - Up to 24 months post-procedure

Participants are followed for up to 24 months after surgery to assess device performance, fusion success, pain resolution, stabilization, and deformity correction.

Regular follow-up visits up to 24 months

Trial Site Locations

Total: 27 locations

1

University of Arizona

Tucson, Arizona, United States, 85721

Actively Recruiting

2

OrthoArkansas

Little Rock, Arkansas, United States, 72204

Actively Recruiting

3

University of California Davis Medical Center

Sacramento, California, United States, 95816

Actively Recruiting

4

University of California, San Francisco (UCSF)

San Francisco, California, United States, 94143

Actively Recruiting

5

Indiana University School of Medicine

Bloomington, Indiana, United States, 47401

Actively Recruiting

6

Indiana Spine Group

Carmel, Indiana, United States, 46032

Actively Recruiting

7

The Orthopaedic Research Foundation (OrthoIndy)

Indianapolis, Indiana, United States, 46278

Actively Recruiting

8

Norton Leatherman Spine Specialists

Louisville, Kentucky, United States, 40202

Actively Recruiting

9

University of Maryland Medical Center

Baltimore, Maryland, United States, 21201

Actively Recruiting

10

Michigan Orthopaedic & Spine Surgeons

Rochester Hills, Michigan, United States, 48307

Actively Recruiting

11

University of Minnesota

Minneapolis, Minnesota, United States, 55454

Actively Recruiting

12

Washington University School of Medicine

St Louis, Missouri, United States, 63110-1010

Actively Recruiting

13

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

14

University at Buffalo

Buffalo, New York, United States, 14221

Actively Recruiting

15

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

16

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

17

University of Pittsburgh Medical Center UPMC Presbyterian

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

18

Rhode Island Hospital University Orthopedic

Providence, Rhode Island, United States, 02914

Actively Recruiting

19

Tennessee Orthopaedic Alliance

Nashville, Tennessee, United States, 37209

Actively Recruiting

20

American Neurospine Institute, PLLC

Frisco, Texas, United States, 75033

Actively Recruiting

21

University of Virginia Health System

Charlottesville, Virginia, United States, 22903

Actively Recruiting

22

Virginia Spine Institute

Reston, Virginia, United States, 20191

Actively Recruiting

23

Centre Hospitalier Universitaire Dijon Bourgogne

Dijon, Bourgogne-Franche-Comté, France, 21079

Actively Recruiting

24

Hôpital Roger Salengro

Lille, France, 59037

Actively Recruiting

25

Centro Hospitalar Universitário São João

Porto, Portugal, 4200-319

Actively Recruiting

26

Hospital Vall D'Hebron

Barcelona, Spain, 08035

Actively Recruiting

27

Kings College Hospital NHS Foundation Trust

London, United Kingdom, SE5 9RS

Actively Recruiting

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Research Team

L

Lauren Oien

E

Erwan Diarra

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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