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)
Rod fracture (RF) — 2 years Incidence of rod fracture(s)
Trial sites (17)
Facility
City
Region
Status
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
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.
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