Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions
NCT ID: NCT06368245
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1244 participants
OBSERVATIONAL
2025-03-24
2029-07-31
Brief Summary
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Detailed Description
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All participating surgeons will be asked to identify a time point, denoted as X, when they started using predominantly either supplementary rod constructs or dual-rod constructs for long-segment posterior TL instrumented spinal fusion. This time point X must be on or before December 31, 2020 (the last eligible date for the index surgery). Participating surgeons will be instructed to select the time point X to be as early within the collection window as feasible to maximize the available FU period.
Once the time point X is identified for a participating surgeon, medical records of patients treated by this surgeon will be reviewed to identify consecutive eligible patients with the index surgery done between the time point X and December 31, 2020, inclusive. In the case that an eligible patient had undergone several surgeries during this period, the first primary or revision of long-segment posterior TL instrumented fusion using either a supplementary rod construct or a dual-rod construct is defined as the index surgery.
Patients will then be grouped based on the rod constructs into either the supplementary rod construct group or dual-rod construct group.
The study has two FU periods:
* The first FU period is the first 2 years after the index surgery. The primary analysis will be done using data from the first 2 years of FU.
* The second FU period ends on December March 31, 20232024. The duration of this FU therefore ranges from 3 years and 3 months to 10 years and 3 months.
The primary study endpoint is the occurrence of the first RF within 2 years after the index surgery.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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primary/revision long-segment posterior TL instrumented fusion with dual-rod constructs
The index surgery for this study is the primary or revision of long-segment posterior TL instrumented fusion using dual-rod construct.
long-segment posterior TL instrumented fusion
long-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs.
primary/revision long-segment posterior TL instrumented fusion with supplementary rod constructs
The index surgery for this study is the primary or revision of long-segment posterior TL instrumented fusion using either a supplementary rod construct.
long-segment posterior TL instrumented fusion
long-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs.
Interventions
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long-segment posterior TL instrumented fusion
long-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs.
Eligibility Criteria
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Inclusion Criteria
* 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 tumor.
* Spinal fusion performed for infection.
* Patients with Parkinson's Disease.
* Patients with neuromuscular disorders.
* Patients with spine malignancies requiring chemo- or radiation therapy.
45 Years
ALL
No
Sponsors
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AO Foundation, AO Spine
OTHER
Responsible Party
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Principal Investigators
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Justin S Smith, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor of Neurosurgery Chief of Spine Division, Fellowship Director University of Virginia
Locations
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Stanford Spine Clinic
Redwood City, California, United States
University of California
Sacramento, California, United States
UCSF Spine Center
San Francisco, California, United States
John Hopkis Hospital
Baltimore, Maryland, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Washington University in St. Louis, School of Medicine
St Louis, Missouri, United States
Washington University in St. Louis, School of Medicine, Saint Louis, Missouri 63110
St Louis, Missouri, United States
Columbia University / NYP Och Spine Hospital
New York, New York, United States
University of Virginia
Charlottesville, Virginia, United States
University of Calgary Spine
Calgary, , Canada
University of Toronto
Toronto, , Canada
Duchess of Kent Children's Hospital
Hong Kong, , China
Kothari Medical Centre
Kolkata, , India
Hamamatsu University School of Medicine
Hamamatsu, , Japan
University of Tokyo
Tokyo, , Japan
Hospital Vall d´Hebron
Barcelona, , Spain
Acibadem Maslak Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Christopher Ames
Role: primary
Khaled Kebaish
Role: primary
Brian Neuman
Role: primary
Munish Gupta
Role: primary
Zeeshan Sardar
Role: primary
Ganesh Swamy
Role: primary
Stephen Lewis
Role: primary
Christopher Nielsen
Role: backup
Kenny Kwan
Role: primary
Shin Oe
Role: primary
So Kato, Prof
Role: primary
Other Identifiers
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SMART
Identifier Type: -
Identifier Source: org_study_id
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