Clinical trial NCT05856370: The Ailliance Post-Market Clinical Study
Official title: The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Deformity
Spinal Degenerative Disorder
Spinal Fusion Failure
Spinal Trauma
Spinal Tumor Case
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
Collaborators: name: Medtronic Cardiac Rhythm and Heart Failure
First posted: 2023-05-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
measure: Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)
timeFrame: Discharge (from Index Surgery completion to 14 days post-operatively)
measure: Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used)
timeFrame: 12 months
measure: Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)
timeFrame: Index Surgery
measure: Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)
timeFrame: 24 months
measure: Pain Resolution (for select Medtronic eligible market-released Other Spinal Hardware device(s) used)
timeFrame: 12 months
measure: Stabilization (for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware)
timeFrame: Up to 12 months
measure: Deformity Correction (for specified Medtronic eligible market-released device(s) used from the following product groups: Spinal Tethers)
timeFrame: 12 months
Secondary outcomes:
measure: Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards
timeFrame: 24 months
measure: Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Rods and Screws]
timeFrame: Up to 12 months
measure: Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws]
timeFrame: 12 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF)
state: California
city: Bloomington
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Indianapolis
country: United States
facility: The Orthopaedic Research Foundation (OrthoIndy)
state: Indiana
city: Louisville
country: United States
facility: Norton Leatherman Spine Specialists
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Rochester Hills
country: United States
facility: Michigan Orthopaedic & Spine Surgeons
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center UPMC Presbyterian
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital University Orthopedic
state: Rhode Island
city: Nashville
country: United States
facility: Tennessee Orthopaedic Alliance
state: Tennessee
city: Frisco
country: United States
facility: American Neurospine Institute, PLLC
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Reston
country: United States
facility: Virginia Spine Institute
state: Virginia
city: Lille
country: France
facility: Hôpital Roger Salengro
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
Study officials:
References: