Trial Title:
The Ailliance Post-Market Clinical Study
NCT ID:
NCT05856370
Condition:
Spinal Deformity
Spinal Degenerative Disorder
Spinal Fusion Failure
Spinal Trauma
Spinal Tumor Case
Conditions: Official terms:
Spinal Cord Neoplasms
Spinal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Follow-up schedule: pre-operative baseline to index surgery
Description:
Follow-up assessments will be required (therefore interventional) from pre-operative
baseline to index surgery for those receiving eligible Medtronic Powered Systems,
Instruments, and Imaging device(s)
Arm group label:
Receiving eligible Medtronic Powered Systems, Instruments, and Imaging device(s)
Intervention type:
Device
Intervention name:
Follow-up schedule: pre-operative baseline to discharge
Description:
Follow-up assessments will be required (therefore interventional) from pre-operative
baseline to index surgery for those receiving eligible Advanced Energy device(s)
Arm group label:
Receiving eligible Advanced Energy device(s)
Intervention type:
Device
Intervention name:
Follow-up schedule: pre-operative baseline up to 24-months post-procedure
Description:
Follow-up assessments will be required (therefore interventional) from pre-operative
baseline to index surgery for those receiving eligible Medtronic Robotics and Navigation,
Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware
device(s)
Arm group label:
Receiving eligible device(s) from all other product groups
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 for up to 24 months. The Ailliance
clinical study is intended to collect data congruous with routine clinical care
practices.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco (UCSF)
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Terry Nguyen
Email:
terry.nguyen@ucsf.edu
Investigator:
Last name:
Aaron Clark, MD
Email:
Principal Investigator
Facility:
Name:
Indiana University School of Medicine
Address:
City:
Bloomington
Zip:
47401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Carolyn York O'Neil
Email:
caoneil@iu.edu
Investigator:
Last name:
David Stockwell, MD
Email:
Principal Investigator
Facility:
Name:
Indiana Spine Group
Address:
City:
Carmel
Zip:
46032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sheetal Vinayek
Email:
svinayek@indianaspinegroup.com
Investigator:
Last name:
Joseph Smucker, MD
Email:
Principal Investigator
Facility:
Name:
The Orthopaedic Research Foundation (OrthoIndy)
Address:
City:
Indianapolis
Zip:
46278
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melanie Glover
Email:
mglover@orthoindy.com
Investigator:
Last name:
Craig McMains, MD
Email:
Principal Investigator
Facility:
Name:
Norton Leatherman Spine Specialists
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Leah Carreon
Email:
leah.carreon@nortonhealthcare.org
Investigator:
Last name:
Kathryn McCarthy, MD
Email:
Principal Investigator
Facility:
Name:
Michigan Orthopaedic & Spine Surgeons
Address:
City:
Rochester Hills
Zip:
48307
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cecile Pestano
Email:
moss.clinicalresearch@gmail.com
Investigator:
Last name:
Richard Easton, MD
Email:
Principal Investigator
Facility:
Name:
University of Minnesota
Address:
City:
Minneapolis
Zip:
55454
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ifeoluwa Onuoha
Email:
olayi018@umn.edu
Investigator:
Last name:
David Polly, MD
Email:
Principal Investigator
Facility:
Name:
The Ohio State University Wexner Medical Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Allison Garvin
Email:
Allison.Garvin@osumc.edu
Investigator:
Last name:
Stephanus Viljoen, MD
Email:
Principal Investigator
Facility:
Name:
Rhode Island Hospital University Orthopedic
Address:
City:
Providence
Zip:
02914
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mariah Balmaceno-Criss
Email:
mariah_balmaceno-criss@brown.edu
Investigator:
Last name:
Alan Daniels, MD
Email:
Principal Investigator
Facility:
Name:
Tennessee Orthopaedic Alliance
Address:
City:
Nashville
Zip:
37209
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erika Frazier
Email:
frazieree@toa.com
Investigator:
Last name:
Ryan Snowden, MD
Email:
Principal Investigator
Facility:
Name:
American Neurospine Institute, PLLC
Address:
City:
Frisco
Zip:
75033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nazia Begum
Email:
nazia.begum@hcahealthcare.com
Investigator:
Last name:
Ripul Panchal, DO
Email:
Principal Investigator
Start date:
May 1, 2023
Completion date:
April 2027
Lead sponsor:
Agency:
Medtronic Spinal and Biologics
Agency class:
Industry
Collaborator:
Agency:
Medtronic Bakken Research Center
Agency class:
Industry
Source:
Medtronic Spinal and Biologics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05856370
