Recruiting

AillianceThe Ailliance Post-Market Clinical Study

Sponsor:

Medtronic Spinal and Biologics

Code:

NCT05856370

Conditions

Spinal Deformity

Spinal Degenerative Disorder

Spinal Fusion Failure

Spinal Trauma

Spinal Tumor Case

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Follow-up schedule: pre-operative baseline up to 24-months post-procedure

Study Details

Brief summary:

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.

Conditions

Spinal Deformity

Spinal Degenerative Disorder

Spinal Fusion Failure

Spinal Trauma

Spinal Tumor Case

Study ID

NCT05856370

Start date

May 1, 2023

Status verified date

Aug, 2026

Completion date

May, 2031

Anticipated

Primary completion date

May, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Receiving eligible Medtronic device(s) from all product groups

Powered Systems, Instruments, and Imaging device(s), Advanced Energy device(s), Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)

Interventions

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 measure

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 ]

Central Contacts and Locations

Central contacts

Lauren Oien

+17635268124 lauren.k.oien@medtronic.com

Erwan Diarra

+33 7 86 55 72 84 erwan.diarra@medtronic.com

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85721

Contacts

Kylie Lew

klew@arizona.edu

Principal Investigator:

Richard Chua, MD

OrthoArkansas

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

Adams Stevens

Adam.Stevens@orthoarkansas.com

Principal Investigator:

Justin Seale, MD

University of California Davis Medical Center

Recruiting

Sacramento, California, United States, 95816

Contacts

Janice Wang-Polagruto

jfwang@ucdavis.edu

Principal Investigator:

Kee Kim, MD

University of California, San Francisco (UCSF)

Recruiting

San Francisco, California, United States, 94143

Contacts

Terry Nguyen

terry.nguyen@ucsf.edu

Principal Investigator:

Aaron Clark, MD

Indiana University School of Medicine

Recruiting

Bloomington, Indiana, United States, 47401

Contacts

Carolyn York O'Neil

caoneil@iu.edu

Principal Investigator:

David Stockwell, MD

Indiana Spine Group

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Sheetal Vinayek

svinayek@indianaspinegroup.com

Principal Investigator:

Joseph Smucker, MD

The Orthopaedic Research Foundation (OrthoIndy)

Recruiting

Indianapolis, Indiana, United States, 46278

Contacts

Melanie Glover

mglover@orthoindy.com

Principal Investigator:

Craig McMains, MD

Norton Leatherman Spine Specialists

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Leah Carreon

leah.carreon@nortonhealthcare.org

Principal Investigator:

Kathryn McCarthy, MD

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Kaitlyn Henry

khenry@som.umaryland.edu

Principal Investigator:

Timothy Chryssikos, MD, PhD

Michigan Orthopaedic & Spine Surgeons

Recruiting

Rochester Hills, Michigan, United States, 48307

Contacts

Cecile Pestano

moss.clinicalresearch@gmail.com

Principal Investigator:

Richard Easton, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55454

Contacts

Ifeoluwa Onuoha

olayi018@umn.edu

Principal Investigator:

David Polly, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110-1010

Contacts

Kayode Matthew

kayode@wustl.edu

Principal Investigator:

Brian Neuman, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Brigette Bahmani

b.bahmani@wustl.edu

Principal Investigator:

Jacob Greenberg, MD

Rutgers University Department of Neurosurgery

Recruiting

New Brunswick, New Jersey, United States, 08901-2065

Contacts

Christine Yohn

cy253@rwjms.rutgers.edu

Principal Investigator:

Jonathan Sherman, MD

University at Buffalo

Recruiting

Buffalo, New York, United States, 14221

Contacts

Jennifer Gay

jgay@ubns.com

Principal Investigator:

Jeffrey Mullin, MD

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

David Haney

david.haney@uhhospitals.org

Principal Investigator:

Gabriel Smith, MD

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Allison Garvin

Allison.Garvin@osumc.edu

Principal Investigator:

Stephanus Viljoen, MD

Rhode Island Hospital University Orthopedic

Recruiting

Providence, Rhode Island, United States, 02914

Contacts

Mariah Balmaceno-Criss

mariah_balmaceno-criss@brown.edu

Principal Investigator:

Alan Daniels, MD

Tennessee Orthopaedic Alliance

Recruiting

Nashville, Tennessee, United States, 37209

Contacts

Erika Frazier

frazieree@toa.com

Principal Investigator:

Ryan Snowden, MD

American Neurospine Institute, PLLC

Recruiting

Frisco, Texas, United States, 75033

Contacts

Nazia Begum

nazia.begum@hcahealthcare.com

Principal Investigator:

Ripul Panchal, DO

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Milos Lesevic

ml4ec@uvahealth.org

Principal Investigator:

Adam Shimer, MD

Virginia Spine Institute

Recruiting

Reston, Virginia, United States, 20191

Contacts

Nancy Goldbranson

ngold@spinemd.com

Principal Investigator:

Colin Haines, MD

More Information

Sponsor

Medtronic Spinal and Biologics

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Medtronic Spinal and Biologics on 2026-08-17.