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Massive spine device registry launches to see how medtronic tools perform in real surgeries

NCT ID NCT05856370

Knowledge-focused Sponsor: Medtronic Spinal and Biologics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 18, 2026 · Updated 7 times

Summary

This study will follow 1,000 people receiving Medtronic spinal or cranial devices during routine surgery. Researchers will track outcomes like fusion success, pain relief, and device safety for up to two years. The goal is to gather real-world data on how these already-approved products perform in everyday clinical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Medtronic spinal and cranial devices (hardware, biologics, robotics, imaging, and energy tools)
What this could lead to
If successful, this study will provide real-world evidence on how well these already-approved devices work in everyday practice, potentially improving surgical guidelines and patient outcomes.
What could go wrong
This is an observational-style post-market study, not a controlled trial. It cannot prove cause and effect, and results may be influenced by differences in patient care or surgeon technique.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

spinal cord neoplasm spinal injury spondylosis vertebral column disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spinal deformity Spinal degenerative disorder Spinal fusion failure Spinal trauma Spinal tumor case

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • American Neurospine Institute, PLLC

    RECRUITING

    Frisco, Texas, 75033, United States

  • Centre Hospitalier Universitaire Dijon Bourgogne

    RECRUITING

    Dijon, Bourgogne-Franche-Comté, 21079, France

  • Centro Hospitalar Universitário São João

    RECRUITING

    Porto, 4200-319, Portugal

  • Charité - Universitätsmedizin Berlin

    RECRUITING

    Berlin, 10117, Germany

  • Hospital Vall D'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hôpital Roger Salengro

    RECRUITING

    Lille, 59037, France

  • Indiana Spine Group

    RECRUITING

    Carmel, Indiana, 46032, United States

  • Indiana University School of Medicine

    RECRUITING

    Bloomington, Indiana, 47401, United States

  • Kings College Hospital NHS Foundation Trust

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Michigan Orthopaedic & Spine Surgeons

    RECRUITING

    Rochester Hills, Michigan, 48307, United States

  • Norton Leatherman Spine Specialists

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • OrthoArkansas

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Rhode Island Hospital University Orthopedic

    RECRUITING

    Providence, Rhode Island, 02914, United States

  • Rutgers University Department of Neurosurgery

    RECRUITING

    New Brunswick, New Jersey, 08901-2065, United States

  • Tennessee Orthopaedic Alliance

    RECRUITING

    Nashville, Tennessee, 37209, United States

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Orthopaedic Research Foundation (OrthoIndy)

    RECRUITING

    Indianapolis, Indiana, 46278, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University at Buffalo

    RECRUITING

    Buffalo, New York, 14221, United States

  • University of Arizona

    RECRUITING

    Tucson, Arizona, 85721, United States

  • University of California Davis Medical Center

    RECRUITING

    Sacramento, California, 95816, United States

  • University of California, San Francisco (UCSF)

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Maryland Medical Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55454, United States

  • University of Pittsburgh Medical Center UPMC Presbyterian

    ACTIVE_NOT_RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Virginia Health System

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Virginia Spine Institute

    RECRUITING

    Reston, Virginia, 20191, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110-1010, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.