Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions

Last updated: March 2, 2026
Sponsor: AO Foundation, AO Spine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Surgery

Spine Athroplasty

Treatment

long-segment posterior TL instrumented fusion

Clinical Study ID

NCT06368245
SMART
  • Ages > 45
  • All Genders

Study Summary

This is a multicenter retrospective comparative cohort study. The index surgery for this study is primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. Eligible patients who already had index surgery, will be identified for enrollment through a review of medical records of the participating surgeons at the study sites.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 45 years and older.

  • Patients receiving long-segment posterior TL instrumented fusion using eithersupplementary rod constructs or dual-rod constructs (the index surgery).

  • Long-segment is defined as the UIV at a thoracic level and the LIV at thesacrum/ilium.

  • Supplementary rod constructs are defined as: in addition to the traditional twoprimary rods, at least one supplementary rod (eg, accessory rods or satelliterods) is used, and at least one supplementary rod and one primary rod (ie, atleast two rods) together must span multiple (≥ 2) vertebral levels. Thesupplementary rod constructs do not include rods connected end-to-end orside-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 butcan 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 therevision surgery, with the exception of Harrington or Luque rods which can remain inplace. o If the Harrington or Luque rods remain in situ, they must already have the UIV atthe thoracic level and the LIV at the sacrum/ilium, or an extension of the existingHarrington or Luque is performed such that the UIV is at the thoracic level and theLIV 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 approvedprocedures if applicable for retrospective data analysis.

Exclusion

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.

Study Design

Total Participants: 1244
Treatment Group(s): 1
Primary Treatment: long-segment posterior TL instrumented fusion
Phase:
Study Start date:
March 24, 2025
Estimated Completion Date:
July 31, 2029

Study Description

This multicenter retrospective comparative cohort study will enroll 1244 patients, who underwent primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. By comparing two groups of patients, ie, patients treated with supplementary rod constructs vs dual-rod constructs, in the setting of long-segment posterior instrumented spinal fusion, this study aims to provide quality evidence regarding the benefits of supplementary rod constructs in reducing the risk of RFs and other mechanical complications. This study shall provide the first long-term clinical evidence on clinical outcome and benefit of supplementary rod constructs.

All participating surgeons will be asked to identify a time point, denoted as X, when they started using predominantly either supplementary rod constructs or dual-rod constructs for long-segment posterior TL instrumented spinal fusion. This time point X must be on or before December 31, 2020 (the last eligible date for the index surgery). Participating surgeons will be instructed to select the time point X to be as early within the collection window as feasible to maximize the available FU period.

Once the time point X is identified for a participating surgeon, medical records of patients treated by this surgeon will be reviewed to identify consecutive eligible patients with the index surgery done between the time point X and December 31, 2020, inclusive. In the case that an eligible patient had undergone several surgeries during this period, the first primary or revision of long-segment posterior TL instrumented fusion using either a supplementary rod construct or a dual-rod construct is defined as the index surgery.

Patients will then be grouped based on the rod constructs into either the supplementary rod construct group or dual-rod construct group.

The study has two FU periods:

  • The first FU period is the first 2 years after the index surgery. The primary analysis will be done using data from the first 2 years of FU.

  • The second FU period ends on December March 31, 20232024. The duration of this FU therefore ranges from 3 years and 3 months to 10 years and 3 months.

The primary study endpoint is the occurrence of the first RF within 2 years after the index surgery.

Connect with a study center

  • University of Calgary Spine

    Calgary, T2N 2T9
    Canada

    Active - Recruiting

  • University of Calgary Spine

    Calgary 5913490, T2N 2T9
    Canada

    Site Not Available

  • University of Toronto

    Toronto, M5T 2S8
    Canada

    Active - Recruiting

  • University of Toronto

    Toronto 6167865, M5T 2S8
    Canada

    Site Not Available

  • Duchess of Kent Children's Hospital

    Hong Kong,
    China

    Active - Recruiting

  • Duchess of Kent Children's Hospital

    Hong Kong 1819729,
    China

    Site Not Available

  • Kothari Medical Centre

    Kolkata,
    India

    Active - Recruiting

  • Kothari Medical Centre

    Kolkata 1275004,
    India

    Site Not Available

  • Hamamatsu University School of Medicine

    Hamamatsu, 431-3192
    Japan

    Active - Recruiting

  • Hamamatsu University School of Medicine

    Hamamatsu 1863289, 431-3192
    Japan

    Site Not Available

  • University of Tokyo

    Tokyo, 113-8654
    Japan

    Active - Recruiting

  • University of Tokyo

    Tokyo 1850147, 113-8654
    Japan

    Site Not Available

  • Hospital Vall d´Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Vall d´Hebron

    Barcelona 3128760, 08035
    Spain

    Site Not Available

  • Acibadem Maslak Hospital

    Istanbul,
    Turkey

    Site Not Available

  • Acibadem Maslak Hospital

    Istanbul,
    Turkey (Türkiye)

    Site Not Available

  • Acibadem Maslak Hospital

    Istanbul 745044,
    Turkey (Türkiye)

    Site Not Available

  • Stanford Spine Clinic

    Redwood City, California 94588
    United States

    Active - Recruiting

  • University of California

    Sacramento, California 95819
    United States

    Active - Recruiting

  • UCSF

    San Francisco, California 94143
    United States

    Site Not Available

  • UCSF Spine Center

    San Francisco, California 94144
    United States

    Active - Recruiting

  • Stanford Spine Clinic

    Redwood City 5386834, California 5332921 94588
    United States

    Site Not Available

  • University of California

    Sacramento 5389489, California 5332921 95819
    United States

    Site Not Available

  • UCSF Spine Center

    San Francisco 5391959, California 5332921 94144
    United States

    Site Not Available

  • John Hopkis Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • John Hopkis Hospital

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • University of Minnesota Medical Center

    Minneapolis, Minnesota 55454
    United States

    Active - Recruiting

  • University of Minnesota Medical Center

    Minneapolis 5037649, Minnesota 5037779 55454
    United States

    Site Not Available

  • Washington University in St. Louis, School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University in St. Louis, School of Medicine

    St Louis, Missouri 63110
    United States

    Active - Recruiting

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

    St Louis, Missouri 63310
    United States

    Active - Recruiting

  • Washington University in St. Louis, School of Medicine

    Washington, Missouri 63110
    United States

    Site Not Available

  • Washington University in St. Louis, School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

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

    St Louis 4407066, Missouri 4398678 63310
    United States

    Active - Recruiting

  • Columbia University / NYP Och Spine Hospital

    New York, New York 10032
    United States

    Active - Recruiting

  • Columbia University / NYP Och Spine Hospital

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • University of Virginia

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • University of Virginia

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Site Not Available

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