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

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.

Conditions

Spinal Fusion

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Spinal Fusion
Intervention / Treatment

-

Contacts and Locations

Redwood City

Stanford Spine Clinic, Redwood City, California, United States, 94588

Sacramento

University of California, Sacramento, California, United States, 95819

San Francisco

UCSF Spine Center, San Francisco, California, United States, 94144

Baltimore

John Hopkis Hospital, Baltimore, Maryland, United States, 21287

Minneapolis

University of Minnesota Medical Center, Minneapolis, Minnesota, United States, 55454

Saint Louis

Washington University in St. Louis, School of Medicine, Saint Louis, Missouri, United States, 63110

New York

Columbia University / NYP Och Spine Hospital, New York, New York, United States, 10032

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22908

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.
  • * 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.

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2029-07-31