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

RecruitingObservational study

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

Who can join

Ages 45 and older · All sexes

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.

About the study

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.

What is being tested

Sponsor: AO Foundation, AO Spine · Participants: 1,244 · Started: Mar 24, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06368245

Locations in the U.S.

CaliforniaStanford Spine Clinic, Redwood City
University of California, Sacramento
UCSF Spine Center, San Francisco
MarylandJohn Hopkis Hospital, Baltimore
MinnesotaUniversity of Minnesota Medical Center, Minneapolis
MissouriWashington University in St. Louis, School of Medicine, St Louis
New YorkColumbia University / NYP Och Spine Hospital, New York
VirginiaUniversity of Virginia, Charlottesville

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.