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Phase not statedRecruitingObservationalNCT06368245

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

Durability of Supplementary Rod Constructs-SuppleMentAry Rod Technique (SMART)-for Long-segment Posterior Instrumented Spinal Fusion Procedures: A Multicenter Retrospective Comparative Study With Dual-rod Constructs

  • Spinal Fusion
I want to take partRefer a patient1 site in India · 17 worldwide

At a glance

Phase
Phase not stated
Study type
Observational
Sponsor
AO Foundation, AO Spine
Enrolment target
1,244
Started
24 March 2025
Main results due (estimated)
15 December 2027
Study ends (estimated)
31 July 2029
Observational model
Cohort
Time perspective
Retrospective
Sites
17 · 1 in India
First posted
16 April 2024
Registry updated
1 October 2026

Can you take part?

  • Aged 45 years and over.
  • Open to any sex.
  • You need the condition being studied. Healthy volunteers are not accepted.
  • Who they are looking for: Patients who underwent long-segment posterior thoracolumbar (TL) instrumented fusion

Age groups: adult, older adult. Sampling: non probability sample.

These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Read the detailed 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.

What participants receive

  • primary/revision long-segment posterior TL instrumented fusion with dual-rod constructs

    The index surgery for this study is the primary or revision of long-segment posterior TL instrumented fusion using dual-rod construct.

    Procedure: long-segment posterior TL instrumented fusion

  • primary/revision long-segment posterior TL instrumented fusion with supplementary rod constructs

    The index surgery for this study is the primary or revision of long-segment posterior TL instrumented fusion using either a supplementary rod construct.

    Procedure: long-segment posterior TL instrumented fusion

Interventions

  • long-segment posterior TL instrumented fusionProcedure

    long-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs.

What the study measures

Primary outcomes

  1. Rod fracture (RF)

    Incidence of rod fracture(s)

    Time frame: 2 years

Secondary outcomes

  1. Time to rod fracture

    Time to the first rod fracture after index surgery

    Time frame: 2 years

  2. Time to rod fracture

    Time to the first rod fracture after index surgery

    Time frame: 10 years and 3 months

  3. Configurations of supplementary rod constructs

    Descriptions of configurations of supplementary rod constructs

    Time frame: Baseline

  4. Treatment for rod fracture

    Descriptions of different treatment strategies for rod fractures

    Time frame: 10 years and 3 months

  5. Recurrent RFs

    Incidence of recurrent rod fractures

    Time frame: 10 years and 3 months

  6. Other mechanical failures

    Other mechanical failures other than rod fractures

    Time frame: 10 years and 3 months

  7. Surgical complications

    Selective surgical complications

    Time frame: 10 years and 3 months

Who is running it

Lead sponsor
AO Foundation, AO Spine
Sponsor type
Other
Responsible party
The sponsor
Organisation
AO Foundation, AO Spine
Data monitoring committee
No
US FDA-regulated drug
No
US FDA-regulated device
No
Sponsor's study ID
SMART

  • Justin S Smith, MD, PhD

    Principal investigator

    Professor of Neurosurgery Chief of Spine Division, Fellowship Director University of Virginia

Study sites(17)

  • Kothari Medical Centre

    Kolkata, India

    Recruiting

  • Stanford Spine Clinic

    Redwood City, California, United States

    Recruiting

  • University of California

    Sacramento, California, United States

    Recruiting

  • John Hopkis Hospital

    Baltimore, Maryland, United States

    Recruiting

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, United States

    Recruiting

  • Washington University in St. Louis, School of Medicine

    St Louis, Missouri, United States

    Recruiting

  • Columbia University / NYP Och Spine Hospital

    New York, New York, United States

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, United States

    Recruiting

  • University of Calgary Spine

    Calgary, Canada

    Recruiting

  • University of Toronto

    Toronto, Canada

    Recruiting

  • University of Tokyo

    Tokyo, Japan

    Recruiting

  • Hospital Vall d´Hebron

    Barcelona, Spain

    Recruiting

  • Acibadem Maslak Hospital

    Istanbul, Turkey (Türkiye)

    Recruiting

  • UCSF Spine Center

    San Francisco, California, United States

    Terminated

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

    St Louis, Missouri, United States

    Completed

  • Duchess of Kent Children's Hospital

    Hong Kong, China

    Completed

  • Hamamatsu University School of Medicine

    Hamamatsu, Japan

    Completed

Showing 17 of 17 sites. 13 of 17 on this study are recruiting right now, and 1 is in India. A site can stop enrolling while the study as a whole is still open.

References and data sharing

Participant data shared
Undecided

Source: ClinicalTrials.gov record NCT06368245, status verified September 2026. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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