The Ailliance Post-Market Clinical Study

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Medtronic Spinal and Biologics
Study ID
NCT05856370
Status
Recruiting
Apply to this trial

Conditions

  • Spinal Deformity
  • Spinal Degenerative Disorder
  • Spinal Fusion Failure
  • Spinal Trauma
  • Spinal Tumor Case

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
May 1, 2023
Status verified
Jun 2026
Primary completion
May 31, 2031
Completion
May 31, 2031

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

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)

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) ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85721
Richard Chua, MD (PRINCIPAL_INVESTIGATOR)
OrthoArkansasLittle RockArkansas72204
Adams Stevens
[email protected]
Justin Seale, MD (PRINCIPAL_INVESTIGATOR)
University of California Davis Medical CenterSacramentoCalifornia95816
Janice Wang-Polagruto
[email protected]
Kee Kim, MD (PRINCIPAL_INVESTIGATOR)
University of California, San Francisco (UCSF)San FranciscoCalifornia94143
Terry Nguyen
[email protected]
Aaron Clark, MD (PRINCIPAL_INVESTIGATOR)
Indiana University School of MedicineBloomingtonIndiana47401
Carolyn York O'Neil
[email protected]
David Stockwell, MD (PRINCIPAL_INVESTIGATOR)
Indiana Spine GroupCarmelIndiana46032
Sheetal Vinayek
[email protected]
Joseph Smucker, MD (PRINCIPAL_INVESTIGATOR)
The Orthopaedic Research Foundation (OrthoIndy)IndianapolisIndiana46278
Melanie Glover
[email protected]
Craig McMains, MD (PRINCIPAL_INVESTIGATOR)
Norton Leatherman Spine SpecialistsLouisvilleKentucky40202
Leah Carreon
[email protected]
Kathryn McCarthy, MD (PRINCIPAL_INVESTIGATOR)
University of Maryland Medical CenterBaltimoreMaryland21201
Kaitlyn Henry
[email protected]
Timothy Chryssikos, MD, PhD (PRINCIPAL_INVESTIGATOR)
Michigan Orthopaedic & Spine SurgeonsRochester HillsMichigan48307
Cecile Pestano
[email protected]
Richard Easton, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55454
Ifeoluwa Onuoha
[email protected]
David Polly, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110-1010
Kayode Matthew
[email protected]
Brian Neuman, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Brigette Bahmani
[email protected]
Jacob Greenberg, MD (PRINCIPAL_INVESTIGATOR)
University at BuffaloBuffaloNew York14221
Jennifer Gay
[email protected]
Jeffrey Mullin, MD (PRINCIPAL_INVESTIGATOR)
University Hospitals Cleveland Medical CenterClevelandOhio44106
Gabriel Smith, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State University Wexner Medical CenterColumbusOhio43210
Allison Garvin
[email protected]
Stephanus Viljoen, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical Center UPMC PresbyterianPittsburghPennsylvania15213
Nitin Agarwal, MD (PRINCIPAL_INVESTIGATOR)
Rhode Island Hospital University OrthopedicProvidenceRhode Island02914
Mariah Balmaceno-Criss
[email protected]
Alan Daniels, MD (PRINCIPAL_INVESTIGATOR)
Tennessee Orthopaedic AllianceNashvilleTennessee37209
Erika Frazier
[email protected]
Ryan Snowden, MD (PRINCIPAL_INVESTIGATOR)
American Neurospine Institute, PLLCFriscoTexas75033
Ripul Panchal, DO (PRINCIPAL_INVESTIGATOR)
University of Virginia Health SystemCharlottesvilleVirginia22903
Milos Lesevic
[email protected]
Adam Shimer, MD (PRINCIPAL_INVESTIGATOR)
Virginia Spine InstituteRestonVirginia20191
Nancy Goldbranson
[email protected]
Colin Haines, MD (PRINCIPAL_INVESTIGATOR)

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University of Arizona· Tucson, AZOrthoArkansas· Little Rock, ARUniversity of California Davis Medical Center· Sacramento, CAUniversity of California, San Francisco (UCSF)· San Francisco, CAIndiana University School of Medicine· Bloomington, INIndiana Spine Group· Carmel, IN

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