The Ailliance Post-Market Clinical Study

Not Applicable

Recruiting

• Conditions: Spinal Trauma; Spinal Deformity; Spinal Degenerative Disorder; Spinal Fusion Failure; Spinal Tumor Case

• Registration Number: NCT05856370
• Lead Sponsor: Medtronic Spinal and Biologics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-16
• Study Start: 2023-05-01
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-12
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-07
• Last Update Posted: 2025-07-08
• Primary Completion: 2031-05
• Study Completion: 2031-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)	Discharge (from Index Surgery completion to 14 days post-operatively)	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)	12 months	Fusion success at 12-months is determined through evaluation of radiographic evidence (X-ray and/or CT scan) by the investigator by: (1) Confirming the presence of bone bridging, and (2) if using the Brantigan \& Steffee's Classification scale: a score D and/or E are determined.
Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)	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.; If O-Arm used: whether O-Arm was utilized for validation of implant placement during the surgery.
Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)	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.
Pain Resolution (for select Medtronic eligible market-released Other Spinal Hardware device(s) used)	12 months	Resolution of pain at 12-months when compared to baseline Pain reported by the subject using the Neck Disability Index (NDI) questionnaire
Stabilization (for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware)	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)).
Deformity Correction (for specified Medtronic eligible market-released device(s) used from the following product groups: Spinal Tethers)	12 months	Defined by the change of Cobb angle at 12-month

Secondary Outcome Measures

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

Trial Locations

Locations (22)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

OrthoArkansas; 🇺🇸 Little Rock, Arkansas, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

University of California, San Francisco (UCSF); 🇺🇸 San Francisco, California, United States

Indiana University School of Medicine; 🇺🇸 Bloomington, Indiana, United States

Indiana Spine Group; 🇺🇸 Carmel, Indiana, United States

The Orthopaedic Research Foundation (OrthoIndy); 🇺🇸 Indianapolis, Indiana, United States

Norton Leatherman Spine Specialists; 🇺🇸 Louisville, Kentucky, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Michigan Orthopaedic & Spine Surgeons; 🇺🇸 Rochester Hills, Michigan, United States

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