Comparing two rod techniques for spinal fusion surgery

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

This study is testing whether using a different type of rod in spinal fusion surgery can help prevent problems after the operation for people who have had back surgery.

Quick facts

• Study type: Observational
• Enrollment: 1244 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: AO Foundation, AO Spine (other)
• Drugs / interventions: radiation
• Locations: 17 sites (Redwood City, California and 16 other locations)
• Trial ID: NCT06368245 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 45 years and older who have received long-segment posterior thoracolumbar instrumented fusion using either supplementary or dual-rod constructs.

Not a fit: Patients who have not undergone long-segment posterior thoracolumbar instrumented fusion or are younger than 45 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing spinal fusion.

How similar studies have performed: While this study is exploring a specific comparative approach, similar studies have shown promise in evaluating different surgical techniques in spinal fusion.

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.

Where this trial is running

Redwood City, California and 16 other locations

• Stanford Spine Clinic — Redwood City, California, United States (RECRUITING)
• University of California — Sacramento, California, United States (RECRUITING)
• UCSF Spine Center — San Francisco, 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)
• Washington University in St. Louis, School of Medicine, Saint Louis, Missouri 63110 — St Louis, Missouri, United States (RECRUITING)
• Columbia University / NYP Och Spine Hospital — New York, New York, United States (RECRUITING)
• University of Virginia — Charlottesville, Virginia, United States (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) (NOT_YET_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

Conditions: Spinal Fusion