RECRUITING

The Ailliance Post-Market Clinical Study

Conditions

Spinal Deformity Spinal Degenerative Disorder Spinal Fusion Failure Spinal Trauma Spinal Tumor Case

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-05-01

Study Completion:2031-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05856370

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Katelynn Hamer

CONTACT

630-544-9247

katelynn.m.hamer@medtronic.com

Nuria Mahmood

CONTACT

763-505-4024

nuria.mahmood@medtronic.com

Study Locations (Sites)

University of California Davis Medical Center

Sacramento, California, 95816

United States

University of California, San Francisco (UCSF)

San Francisco, California, 94143

United States

Indiana University School of Medicine

Bloomington, Indiana, 47401

United States

Indiana Spine Group

Carmel, Indiana, 46032

United States

The Orthopaedic Research Foundation (OrthoIndy)

Indianapolis, Indiana, 46278

United States

Norton Leatherman Spine Specialists

Louisville, Kentucky, 40202

United States

Michigan Orthopaedic & Spine Surgeons

Rochester Hills, Michigan, 48307

United States

University of Minnesota

Minneapolis, Minnesota, 55454

United States

University at Buffalo

Buffalo, New York, 14221

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

United States

Rhode Island Hospital University Orthopedic

Providence, Rhode Island, 02914

United States

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37209

United States

American Neurospine Institute, PLLC

Frisco, Texas, 75033

United States

Collaborators and Investigators

Sponsor: Medtronic Spinal and Biologics

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 Registration Dates

Study Start Date2023-05-01

Study Completion Date2031-05

Study Record Updates

Study Start Date2023-05-01

Study Completion Date2031-05

Terms related to this study

Additional Relevant MeSH Terms

Spinal Deformity
Spinal Degenerative Disorder
Spinal Fusion Failure
Spinal Trauma
Spinal Tumor Case