The Ailliance Post-Market Clinical Study

Spinal Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05856370
• Other study ID #: MDT22045CSTAIL
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: Medtronic Spinal and Biologics
• Contact: Katelynn Hamer
• Phone: 630-544-9247
• Email: katelynn.m.hamer[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Neoplasms
• Spinal Deformity
• Spinal Degenerative Disorder
• Spinal Neoplasms
• Spinal Trauma

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Bloomington	Indiana
United States	Indiana Spine Group	Carmel	Indiana
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	American Neurospine Institute, PLLC	Frisco	Texas
United States	The Orthopaedic Research Foundation (OrthoIndy)	Indianapolis	Indiana
United States	Norton Leatherman Spine Specialists	Louisville	Kentucky
United States	University of Minnesota	Minneapolis	Minnesota
United States	Tennessee Orthopaedic Alliance	Nashville	Tennessee
United States	Rhode Island Hospital University Orthopedic	Providence	Rhode Island
United States	Michigan Orthopaedic & Spine Surgeons	Rochester Hills	Michigan
United States	University of California, San Francisco (UCSF)	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics	Medtronic Bakken Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 24 months
Primary	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.	12 months
Primary	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.	Index Surgery
Primary	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.	Up to 24 months
Primary	Deformity correction (for any Medtronic eligible market-released Spinal Tethers device(s) used)	Defined by the change of Cobb angle at 12-month	12 months and up to 24 months
Secondary	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	Up to 24 months
Secondary	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	Up to 12 months
Secondary	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.	Up to 12 months