Comparing two rod techniques for spinal fusion surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter retrospective comparative cohort study evaluates the outcomes of long-segment posterior thoracolumbar instrumented fusion surgeries using either supplementary rod constructs or dual-rod constructs. It aims to enroll 1244 patients who have undergone either primary or revision surgeries, analyzing their medical records to assess the effectiveness of the supplementary rod constructs in reducing risks of mechanical complications. The study will provide long-term clinical evidence on the benefits of these constructs in spinal fusion procedures.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Principal investigator: Justin S Smith, MD, PhD — Professor of Neurosurgery Chief of Spine Division, Fellowship Director University of Virginia
• Study coordinator: Alix Frischknecht
• Email: alix.frischknecht@aofoundation.org
• Phone: +41 79 606 41 48

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.