🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06368245
Recruiting Observational

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

NCT06368245 · tracked via the Priya Life Science China tracker
Sponsor
AO Foundation, AO Spine
Phase
Observational
Started
2025-03-24
Last updated
2026-06-30

Condition(s) studied

Spinal Fusion

Investigational drug(s) / intervention(s)

long-segment posterior TL instrumented fusion

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

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

Sex
ALL
Min age
45 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (17)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06368245 on ClinicalTrials.gov ↗ ← All trials in China