Back to resultsThe Ailliance Post-Market Clinical Study
Primary Purpose
Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Follow-up schedule: pre-operative baseline to index surgery
Follow-up schedule: pre-operative baseline to discharge
Follow-up schedule: pre-operative baseline up to 24-months post-procedure
Sponsored by
About this trial
This is an interventional health services research trial for Spinal Deformity
Eligibility Criteria
Inclusion Criteria: 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 (CST) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s). 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. Exclusion Criteria: 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). Subject who is, or is expected to be, inaccessible for all required follow-up visits. Subject with exclusion criteria required by local law. Subject is considered vulnerable at the time of obtaining consent.
Sites / Locations
- Michigan Orthopaedic & Spine SurgeonsRecruiting
- The Ohio State University Wexner Medical CenterRecruiting
- Rhode Island Hospital University OrthopedicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Receiving eligible Medtronic Powered Systems, Instruments, and Imaging device(s)
Receiving eligible Advanced Energy device(s)
Receiving eligible device(s) from all other product groups
Arm Description
Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)
Outcomes
Primary Outcome Measures
Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)
Defined by amount of: 1) blood loss (mL) during surgery and/or 2) total operation time and/or 3) length of stay in the hospital (measured from surgery completion to discharge), and/or 4) investigator opinion on whether the device(s) directly assisted in the completion of surgery
Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used)
Fusion success at 12-months, as assessed via radiographic evidence.
Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)
Surgical performance, as defined as the rate at which the device directly assisted in the completion of surgery in the investigator's opinion.
Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)
Robotics: Planned number of screws prior to index surgery compared to number of screws device assisted with placement during surgery. Navigation: Whether or not device was utilized for validation of screw placement during surgery.
Deformity correction (for any Medtronic eligible market-released Spinal Tethers device(s) used)
Defined by the change of Cobb angle at 12-month
Secondary Outcome Measures
Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards
The secondary endpoint is defined as the rate of occurrence for device-related adverse events
Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Other Spinal Hardware, Rods and Screws]
Stabilization is the radiographic verification of no noticeable hardware and/or implant loosening, the presence of the hardware in the appropriate position without cage subsidence and/or implant loosening, and noticeable stable alignment of the spine post-surgery.
Since all products are market-released, assessment for stabilization will be completed by the investigator.
Stabilization will be assessed by the collection of radiographic evidence (X-Ray(s) and CT-scan(s)).
[For Other Spinal Hardware device(s) used]: when radiographic fusion is not evident or no fusion is noted, stabilization will be assessed as a secondary endpoint
Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws]
Deformity correction is defined by the change of Cobb angle at the 12-month postoperative visit compared to baseline.
Assessment(s) for deformity correction will be completed by the investigator. The investigator will determine whether the subject meets requirements of deformity correction based on the comparison of the Cobb angle measurements at all postoperative visits, when compared to the subject's baseline assessments.
Cobb angle measurements will be provided through collection of radiographic evidence (X-Ray(s) and CT-scan(s)) and assessed by the investigator.
Full Information
NCT ID
NCT05856370
First Posted
March 16, 2023
Last Updated
October 20, 2023
Sponsor
Medtronic Spinal and Biologics
Collaborators
Medtronic Bakken Research Center
1. Study Identification
Unique Protocol Identification Number
NCT05856370
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Spinal and Biologics
Collaborators
Medtronic Bakken Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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 for up to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma, Spinal Tumor Case
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Receiving eligible Medtronic Powered Systems, Instruments, and Imaging device(s)
Arm Type
Other
Arm Title
Receiving eligible Advanced Energy device(s)
Arm Type
Other
Arm Title
Receiving eligible device(s) from all other product groups
Arm Type
Other
Arm Description
Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)
Intervention Type
Device
Intervention Name(s)
Follow-up schedule: pre-operative baseline to index surgery
Intervention 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)
Intervention Type
Device
Intervention Name(s)
Follow-up schedule: pre-operative baseline to discharge
Intervention Description
Follow-up assessments will be required (therefore interventional) from pre-operative baseline to index surgery for those receiving eligible Advanced Energy device(s)
Intervention Type
Device
Intervention Name(s)
Follow-up schedule: pre-operative baseline up to 24-months post-procedure
Intervention 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)
Primary Outcome Measure Information:
Title
Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)
Description
Defined by amount of: 1) blood loss (mL) during surgery and/or 2) total operation time and/or 3) length of stay in the hospital (measured from surgery completion to discharge), and/or 4) investigator opinion on whether the device(s) directly assisted in the completion of surgery
Time Frame
Up to 24 months
Title
Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used)
Description
Fusion success at 12-months, as assessed via radiographic evidence.
Time Frame
12 months
Title
Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)
Description
Surgical performance, as defined as the rate at which the device directly assisted in the completion of surgery in the investigator's opinion.
Time Frame
Index Surgery
Title
Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)
Description
Robotics: Planned number of screws prior to index surgery compared to number of screws device assisted with placement during surgery. Navigation: Whether or not device was utilized for validation of screw placement during surgery.
Time Frame
Up to 24 months
Title
Deformity correction (for any Medtronic eligible market-released Spinal Tethers device(s) used)
Description
Defined by the change of Cobb angle at 12-month
Time Frame
12 months and up to 24 months
Secondary Outcome Measure Information:
Title
Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards
Description
The secondary endpoint is defined as the rate of occurrence for device-related adverse events
Time Frame
Up to 24 months
Title
Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Other Spinal Hardware, Rods and Screws]
Description
Stabilization is the radiographic verification of no noticeable hardware and/or implant loosening, the presence of the hardware in the appropriate position without cage subsidence and/or implant loosening, and noticeable stable alignment of the spine post-surgery.
Since all products are market-released, assessment for stabilization will be completed by the investigator.
Stabilization will be assessed by the collection of radiographic evidence (X-Ray(s) and CT-scan(s)).
[For Other Spinal Hardware device(s) used]: when radiographic fusion is not evident or no fusion is noted, stabilization will be assessed as a secondary endpoint
Time Frame
Up to 12 months
Title
Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws]
Description
Deformity correction is defined by the change of Cobb angle at the 12-month postoperative visit compared to baseline.
Assessment(s) for deformity correction will be completed by the investigator. The investigator will determine whether the subject meets requirements of deformity correction based on the comparison of the Cobb angle measurements at all postoperative visits, when compared to the subject's baseline assessments.
Cobb angle measurements will be provided through collection of radiographic evidence (X-Ray(s) and CT-scan(s)) and assessed by the investigator.
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 (CST) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s).
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.
Exclusion Criteria:
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).
Subject who is, or is expected to be, inaccessible for all required follow-up visits.
Subject with exclusion criteria required by local law.
Subject is considered vulnerable at the time of obtaining consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katelynn Hamer
Phone
630-544-9247
Email
katelynn.m.hamer@medtronic.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nuria Mahmood
Phone
763-505-4024
Email
nuria.mahmood@medtronic.com
Facility Information:
Facility Name
Michigan Orthopaedic & Spine Surgeons
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecile Pestano
Email
moss.clinicalresearch@gmail.com
First Name & Middle Initial & Last Name & Degree
Richard Easton, MD
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Garvin
Email
Allison.Garvin@osumc.edu
First Name & Middle Initial & Last Name & Degree
Stephanus Viljoen, MD
Facility Name
Rhode Island Hospital University Orthopedic
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariah Balmaceno-Criss
Email
mariah_balmaceno-criss@brown.edu
First Name & Middle Initial & Last Name & Degree
Alan Daniels, MD
12. IPD Sharing Statement
Learn more about this trial
The Ailliance Post-Market Clinical Study
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