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

Recruiting now

Conditions studied: Spinal Fusion

In brief

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.

Key facts

Study ID: NCT06368245
Run by: AO Foundation, AO Spine
People needed: 1244
Starts: 2025-03-24
Expected to finish: 2029-07-31
Last updated by the study team: 2026-06-30

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Acibadem Maslak Hospital — Istanbul, Turkey (Türkiye) (enrolling)
University of California — Sacramento, California, United States (enrolling)
UCSF Spine Center — San Francisco, California, United States (enrolling)
John Hopkis Hospital — Baltimore, Maryland, United States (enrolling)
University of Minnesota Medical Center — Minneapolis, Minnesota, United States (enrolling)
Washington University in St. Louis, School of Medicine — St Louis, Missouri, United States (enrolling)
Stanford Spine Clinic — Redwood City, California, United States (enrolling)
Columbia University / NYP Och Spine Hospital — New York, New York, United States (enrolling)
University of Virginia — Charlottesville, Virginia, United States (enrolling)
University of Calgary Spine — Calgary, Canada (enrolling)
University of Toronto — Toronto, Canada (enrolling)
Duchess of Kent Children's Hospital — Hong Kong, China (enrolling)
Kothari Medical Centre — Kolkata, India (enrolling)
Hamamatsu University School of Medicine — Hamamatsu, Japan (enrolling)
University of Tokyo — Tokyo, Japan (enrolling)
Hospital Vall d´Hebron — Barcelona, Spain (enrolling)
Washington University in St. Louis, School of Medicine, Saint Louis, Missouri 63110 — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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