Wounds and Injuries

All Conditions

Diseases and Abnormalities at or Before Birth

Neoplasms

Nervous System Diseases

Musculoskeletal Diseases

Congenital Abnormalities

Spinal Cord Neoplasms

Spinal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Spinal Cord Diseases

Central Nervous System Diseases

Bone Neoplasms

Bone Diseases

Spinal Diseases

Robotics and Navigation, Rods and Screws, Interbodies and Biologics, Spinal Tethers, and Other Spinal Hardware device(s)

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 index surgery

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 to discharge

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)

Follow-up schedule: pre-operative baseline up to 24-months post-procedure

Katelynn Hamer

Nuria Mahmood

Terry Nguyen

Aaron Clark, MD

Carolyn York O'Neil

David Stockwell, MD

Sheetal Vinayek

Joseph Smucker, MD

Melanie Glover

Craig McMains, MD

Leah Carreon

Kathryn McCarthy, MD

Cecile Pestano

Richard Easton, MD

Ifeoluwa Onuoha

David Polly, MD

Allison Garvin

Stephanus Viljoen, MD

Mariah Balmaceno-Criss

Alan Daniels, MD

Erika Frazier

Ryan Snowden, MD

Nazia Begum

Ripul Panchal, DO

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.

The Ailliance Post-Market Clinical Study

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

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 at 12-months, as assessed via radiographic evidence.

Surgical performance, as defined as the rate at which the device directly assisted in the completion of surgery in the investigator's opinion.

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.

Defined by the change of Cobb angle at 12-month

The secondary endpoint is defined as the rate of occurrence for device-related adverse events

* 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 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Ailliance Post-Market Clinical Study	NCT05856370	Spinal Deformit... Spinal Degenera... Spinal Fusion F... Spinal Trauma Spinal Tumor Ca...	Follow-up sched... Follow-up sched... Follow-up sched...	18 Years -	Medtronic Spinal and Biologics
The Ailliance Post-Market Clinical Study	NCT05856370	Spinal Deformit... Spinal Degenera... Spinal Fusion F... Spinal Trauma Spinal Tumor Ca...	Follow-up sched... Follow-up sched... Follow-up sched...	18 Years -	Medtronic Spinal and Biologics
The Ailliance Post-Market Clinical Study	NCT05856370	Spinal Deformit... Spinal Degenera... Spinal Fusion F... Spinal Trauma Spinal Tumor Ca...	Follow-up sched... Follow-up sched... Follow-up sched...	18 Years -	Medtronic Spinal and Biologics

Spots Global Cancer Trial Database for spinal degenerative disorder