RECRUITING

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

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Conditions

Spinal Fusion

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-24
Study Completion:2029-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06368245

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 45 years and older.
  2. * Patients receiving long-segment posterior TL instrumented fusion using either supplementary rod constructs or dual-rod constructs (the index surgery).
  3. * Long-segment is defined as the UIV at a thoracic level and the LIV at the sacrum/ilium.
  4. * 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.
  5. * The index surgery can be a primary surgery or a revision surgery.
  6. * 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.
  7. * 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.
  8. * The index surgery was performed between January 1, 2014, and December 31, 2020, inclusive.
  9. * Minimum 3 months of FU after the index surgery.
  10. * Ability to provide informed consent according to the IRB/EC defined and approved procedures if applicable for retrospective data analysis.
  1. * Spinal fusion performed for acute trauma (ie, ≤ 1 year of trauma).
  2. * Spinal fusion performed for tumor.
  3. * Spinal fusion performed for infection.
  4. * Patients with Parkinson's Disease.
  5. * Patients with neuromuscular disorders.
  6. * Patients with spine malignancies requiring chemo- or radiation therapy.

Contacts and Locations

Study Contact

Alix Frischknecht
CONTACT
+41 79 606 41 48
alix.frischknecht@aofoundation.org
Joelle Kägi
CONTACT
joelle.kaegi@aofoundation.org

Principal Investigator

Justin S Smith, MD, PhD
PRINCIPAL_INVESTIGATOR
Professor of Neurosurgery Chief of Spine Division, Fellowship Director University of Virginia

Study Locations (Sites)

Stanford Spine Clinic
Redwood City, California, 94588
United States
University of California
Sacramento, California, 95819
United States
UCSF Spine Center
San Francisco, California, 94144
United States
John Hopkis Hospital
Baltimore, Maryland, 21287
United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55454
United States
Washington University in St. Louis, School of Medicine
Saint Louis, Missouri, 63110
United States
Columbia University / NYP Och Spine Hospital
New York, New York, 10032
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: AO Foundation, AO Spine

  • Justin S Smith, MD, PhD, PRINCIPAL_INVESTIGATOR, Professor of Neurosurgery Chief of Spine Division, Fellowship Director University of Virginia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-24
Study Completion Date2029-07-31

Study Record Updates

Study Start Date2025-03-24
Study Completion Date2029-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Fusion