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Which rod setup holds up best in spine surgery? new study aims to find out

NCT ID NCT06368245

Knowledge-focused Sponsor: AO Foundation, AO Spine Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times

Summary

This study looks at two different ways to place metal rods during long spinal fusion surgery to fix the back. Researchers will compare how often the rods break with each method by reviewing medical records of over 1200 patients aged 45 and older. The goal is to find out which technique is more durable and leads to fewer complications.

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.

Participants

About 1,244 people

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

Started

Mar 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients who underwent long-segment posterior thoracolumbar (TL) instrumented fusion

Ages

45 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: * Age 45 years and older. * Patients receiving long-segment posterior TL instrumented fusion using either supplementary rod constructs or dual-rod constructs (the index surgery). * Long-segment is defined as the UIV at a thoracic level and the LIV at the sacrum/ilium. * Supplementary rod constructs are defined as: in addition to the traditional two primary rods, at least one supplementary rod (eg, accessory rods or satellite rods) is used, and at least one supplementary rod and one primary rod (ie, at least two rods) together must span multiple (≥ 2) vertebral levels. The supplementary rod constructs do not include rods connected end-to-end or side-to-side that do not bridge multiple vertebral levels. * The index surgery can be a primary surgery or a revision surgery. * The index surgery, staged or non-staged, must use posterior spinal fusion but can be in combination with other approaches such as an anterior procedure. * If the index surgery is a revision surgery, the primary rods must be replaced in the revision surgery, with the exception of Harrington or Luque rods which can remain in place. o If the Harrington or Luque rods remain in situ, they must already have the UIV at the thoracic level and the LIV at the sacrum/ilium, or an extension of the existing Harrington or Luque is performed such that the UIV is at the thoracic level and the LIV at the sacrum/ilium. * The index surgery was performed between January 1, 2014, and December 31, 2020, inclusive. * Minimum 3 months of FU after the index surgery. * Ability to provide informed consent according to the IRB/EC defined and approved procedures if applicable for retrospective data analysis. Exclusion Criteria: * Spinal fusion performed for acute trauma (ie, ≤ 1 year of trauma). * Spinal fusion performed for tumor. * Spinal fusion performed for infection. * Patients with Parkinson's Disease. * Patients with neuromuscular disorders. * Patients with spine malignancies requiring chemo- or radiation therapy.

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As listed by the trial registrant

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

Spinal fusion

How to take part

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

  1. The places running it

    16 sites in 7 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

  • Acibadem Maslak Hospital

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • Columbia University / NYP Och Spine Hospital

    RECRUITING

    New York, New York, 10032, United States

  • Duchess of Kent Children's Hospital

    RECRUITING

    Hong Kong, China

  • Hamamatsu University School of Medicine

    RECRUITING

    Hamamatsu, 431-3192, Japan

  • Hospital Vall d´Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • John Hopkis Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kothari Medical Centre

    RECRUITING

    Kolkata, India

  • Stanford Spine Clinic

    RECRUITING

    Redwood City, California, 94588, United States

  • UCSF Spine Center

    RECRUITING

    San Francisco, California, 94144, United States

  • University of Calgary Spine

    RECRUITING

    Calgary, T2N 2T9, Canada

  • University of California

    RECRUITING

    Sacramento, California, 95819, United States

  • University of Minnesota Medical Center

    RECRUITING

    Minneapolis, Minnesota, 55454, United States

  • University of Tokyo

    RECRUITING

    Tokyo, 113-8654, Japan

  • University of Toronto

    RECRUITING

    Toronto, M5T 2S8, Canada

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Washington University in St. Louis, School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Washington University in St. Louis, School of Medicine, Saint Louis, Missouri 63110

    COMPLETED

    St Louis, Missouri, 63310, United States

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