Actively Recruiting
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
Eligibility Criteria
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.
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
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
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
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