RecruitingNCT06368245

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


Sponsor

AO Foundation, AO Spine

Enrollment

1,244 participants

Start Date

Mar 24, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 45 Years

Inclusion Criteria11

  • 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 Criteria6

  • 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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Interventions

PROCEDURElong-segment posterior TL instrumented fusion

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


Locations(17)

Stanford Spine Clinic

Redwood City, California, United States

University of California

Sacramento, California, United States

UCSF Spine Center

San Francisco, California, United States

John Hopkis Hospital

Baltimore, Maryland, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Washington University in St. Louis, School of Medicine

St Louis, Missouri, United States

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

St Louis, Missouri, United States

Columbia University / NYP Och Spine Hospital

New York, New York, United States

University of Virginia

Charlottesville, Virginia, United States

University of Calgary Spine

Calgary, Canada

University of Toronto

Toronto, Canada

Duchess of Kent Children's Hospital

Hong Kong, China

Kothari Medical Centre

Kolkata, India

Hamamatsu University School of Medicine

Hamamatsu, Japan

University of Tokyo

Tokyo, Japan

Hospital Vall d´Hebron

Barcelona, Spain

Acibadem Maslak Hospital

Istanbul, Turkey (Türkiye)

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NCT06368245


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