The Ailliance Post-Market Clinical Study

April 26, 2024 updated by: Medtronic Spinal and Biologics

The Ailliance Post-Market Clinical Study: All enablIng technoLogies, bioLogics, IDS, And Core spiNe produCt collEction

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco (UCSF)
        • Contact:
        • Principal Investigator:
          • Aaron Clark, MD
    • Indiana
      • Bloomington, Indiana, United States, 47401
        • Recruiting
        • Indiana University School of Medicine
        • Contact:
        • Principal Investigator:
          • David Stockwell, MD
      • Carmel, Indiana, United States, 46032
      • Indianapolis, Indiana, United States, 46278
        • Recruiting
        • The Orthopaedic Research Foundation (OrthoIndy)
        • Contact:
        • Principal Investigator:
          • Craig McMains, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Michigan
      • Rochester Hills, Michigan, United States, 48307
        • Recruiting
        • Michigan Orthopaedic & Spine Surgeons
        • Contact:
        • Principal Investigator:
          • Richard Easton, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota
        • Contact:
        • Principal Investigator:
          • David Polly, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Principal Investigator:
          • Stephanus Viljoen, MD
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02914
        • Recruiting
        • Rhode Island Hospital University Orthopedic
        • Principal Investigator:
          • Alan Daniels, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Tennessee Orthopaedic Alliance
        • Contact:
        • Principal Investigator:
          • Ryan Snowden, MD
    • Texas
      • Frisco, Texas, United States, 75033
        • Recruiting
        • American Neurospine Institute, PLLC
        • Principal Investigator:
          • Ripul Panchal, DO
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Receiving eligible Medtronic Powered Systems, Instruments, and Imaging device(s)
Device: Follow-up schedule: pre-operative baseline to index surgery
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)
Other: Receiving eligible Advanced Energy device(s)
Device: Follow-up schedule: pre-operative baseline to discharge
Follow-up assessments will be required (therefore interventional) from pre-operative baseline to index surgery for those receiving eligible Advanced Energy device(s)
Other: Receiving eligible device(s) from all other product groups
Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)
Device: Follow-up schedule: pre-operative baseline up to 24-months post-procedure
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)
Time Frame: Up to 24 months
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
Up to 24 months
Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used)
Time Frame: 12 months
Fusion success at 12-months, as assessed via radiographic evidence.
12 months
Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)
Time Frame: Index Surgery
Surgical performance, as defined as the rate at which the device directly assisted in the completion of surgery in the investigator's opinion.
Index Surgery
Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)
Time Frame: Up to 24 months
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.
Up to 24 months
Deformity correction (for any Medtronic eligible market-released Spinal Tethers device(s) used)
Time Frame: 12 months and up to 24 months
Defined by the change of Cobb angle at 12-month
12 months and up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Device-related Adverse Events any Medtronic eligible market-released Cranial & Spinal Technologies (CST) device(s) as aligned with ISO 14155 standards
Time Frame: Up to 24 months
The secondary endpoint is defined as the rate of occurrence for device-related adverse events
Up to 24 months
Stabilization [for any Medtronic eligible market-released device(s) used from the following product groups: Interbodies and Biologics, Other Spinal Hardware, Rods and Screws]
Time Frame: Up to 12 months
  • 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
Up to 12 months
Deformity Correction [for specified Medtronic eligible market-released device(s) used from the following product groups: Rods and Screws]
Time Frame: Up to 12 months
  • 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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Spinal and Biologics

Collaborators

Medtronic Bakken Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 16, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 26, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT22045CSTAIL

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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