The Ailliance Post-Market Clinical Study

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05856370
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Medtronic Spinal and Biologics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma, Spinal Tumor Case
Arms & Interventions

Arms

Other: Receiving eligible Medtronic Powered Systems, Instruments, and Imaging device(s)

Other: 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)

Interventions

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)

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)

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)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Francisco, California

Status

Recruiting

Address

University of California, San Francisco (UCSF)

San Francisco, California, 94143

Site Contact

Terry Nguyen

[email protected]

630-544-9247

Indiana University School of Medicine, Bloomington, Indiana

Status

Recruiting

Address

Indiana University School of Medicine

Bloomington, Indiana, 47401

Site Contact

Carolyn York O'Neil

[email protected]

630-544-9247

Indiana Spine Group, Carmel, Indiana

Status

Recruiting

Address

Indiana Spine Group

Carmel, Indiana, 46032

Site Contact

Sheetal Vinayek

[email protected]

630-544-9247

Indianapolis, Indiana

Status

Recruiting

Address

The Orthopaedic Research Foundation (OrthoIndy)

Indianapolis, Indiana, 46278

Site Contact

Melanie Glover

[email protected]

630-544-9247

Norton Leatherman Spine Specialists, Louisville, Kentucky

Status

Recruiting

Address

Norton Leatherman Spine Specialists

Louisville, Kentucky, 40202

Site Contact

Leah Carreon

[email protected]

630-544-9247

Michigan Orthopaedic & Spine Surgeons, Rochester Hills, Michigan

Status

Recruiting

Address

Michigan Orthopaedic & Spine Surgeons

Rochester Hills, Michigan, 48307

Site Contact

Cecile Pestano

[email protected]

630-544-9247

University of Minnesota, Minneapolis, Minnesota

Status

Recruiting

Address

University of Minnesota

Minneapolis, Minnesota, 55454

Site Contact

Ifeoluwa Onuoha

[email protected]

630-544-9247

Columbus, Ohio

Status

Recruiting

Address

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210

Site Contact

Allison Garvin

[email protected]

630-544-9247

Providence, Rhode Island

Status

Recruiting

Address

Rhode Island Hospital University Orthopedic

Providence, Rhode Island, 02914

Site Contact

Mariah Balmaceno-Criss

[email protected]

630-544-9247

Tennessee Orthopaedic Alliance, Nashville, Tennessee

Status

Recruiting

Address

Tennessee Orthopaedic Alliance

Nashville, Tennessee, 37209

Site Contact

Erika Frazier

[email protected]

630-544-9247

American Neurospine Institute, PLLC, Frisco, Texas

Status

Recruiting

Address

American Neurospine Institute, PLLC

Frisco, Texas, 75033

Site Contact

Nazia Begum

[email protected]

630-544-9247