Actively Recruiting
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
Led by AO Foundation, AO Spine · Updated on 2026-03-04
1244
Participants Needed
17
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who underwent long-segment posterior thoracolumbar (TL) instrumented spinal fusion surgery using either supplementary rod constructs or dual-rod constructs. This multicenter retrospective comparative cohort study aims to provide evidence on whether supplementary rod constructs can reduce the risk of rod fractures and other mechanical complications. The study includes patients who had their index surgery, either primary or revision, performed before December 31, 2020, to assess long-term clinical outcomes. The treatments compared in this study are two types of rod constructs used during long-segment posterior TL instrumented fusion: supplementary rod constructs (which include additional rods beyond the traditional two primary rods spanning multiple vertebral levels) and dual-rod constructs. The study involves grouping patients based on the type of rod construct used during their index surgery. Follow-up is divided into two periods: the first two years after surgery for primary analysis, and a longer period up to over 10 years to assess outcomes such as rod fractures and mechanical failures. Participants are identified retrospectively through medical record review from surgeons at multiple centers. Researchers will collect data on the occurrence and timing of rod fractures, surgical complications, and other mechanical failures. Follow-up durations range from a minimum of three months to over ten years after surgery. The primary outcome measure is the occurrence of the first rod fracture within two years post-surgery. Secondary outcomes include treatment details for rod fractures and recurrence rates over the longer follow-up period.
CONDITIONS
Brief Title
Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 45 years and older
- Patients who had long-segment posterior thoracolumbar instrumented fusion using supplementary rod constructs or dual-rod constructs
- Long-segment is defined as the upper instrumented vertebra at a thoracic level and the lower instrumented vertebra at the sacrum or ilium
- Supplementary rod constructs include at least one additional rod spanning multiple vertebral levels along with primary rods
- The index surgery can be primary or revision surgery
- Revision surgeries must replace primary rods except for Harrington or Luque rods under specific conditions
- The index surgery was performed between January 1, 2014, and December 31, 2020
- Minimum 3 months of follow-up after the index surgery
- Ability to provide informed consent for retrospective data analysis if applicable
You will not qualify if you...
- Spinal fusion performed for acute trauma within 1 year
- Spinal fusion performed for tumor or infection
- Patients with Parkinson's Disease
- Patients with neuromuscular disorders
- Patients with spine malignancies requiring chemotherapy or radiation therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Variable retrospective period prior to surgery
Participants are screened for eligibility to participate in the trial.
Review of medical records
Duration - Index surgery date (between January 1, 2014 and December 31, 2020)
Participants underwent primary or revision long-segment posterior thoracolumbar instrumented fusion using either supplementary rod constructs or dual-rod constructs.
Single surgical procedure
Duration - Up to approximately 10 years and 3 months after surgery
Participants are observed for clinical outcomes and mechanical complications related to the rod constructs after surgery.
Data collected from medical records during follow-up periods, including first 2 years and beyond
Trial Site Locations
Total: 17 locations
1
Stanford Spine Clinic
Redwood City, California, United States, 94588
Actively Recruiting
2
University of California
Sacramento, California, United States, 95819
Actively Recruiting
3
UCSF Spine Center
San Francisco, California, United States, 94144
Actively Recruiting
4
John Hopkis Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
6
Washington University in St. Louis, School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Washington University in St. Louis, School of Medicine, Saint Louis, Missouri 63110
St Louis, Missouri, United States, 63310
Actively Recruiting
8
Columbia University / NYP Och Spine Hospital
New York, New York, United States, 10032
Actively Recruiting
9
University of Virginia
Charlottesville, Virginia, United States, 22908
Actively Recruiting
10
University of Calgary Spine
Calgary, Canada, T2N 2T9
Actively Recruiting
11
University of Toronto
Toronto, Canada, M5T 2S8
Actively Recruiting
12
Duchess of Kent Children's Hospital
Hong Kong, China
Actively Recruiting
13
Kothari Medical Centre
Kolkata, India
Actively Recruiting
14
Hamamatsu University School of Medicine
Hamamatsu, Japan, 431-3192
Actively Recruiting
15
University of Tokyo
Tokyo, Japan, 113-8654
Actively Recruiting
16
Hospital Vall d´Hebron
Barcelona, Spain, 08035
Actively Recruiting
17
Acibadem Maslak Hospital
Istanbul, Turkey (Türkiye)
Not Yet Recruiting
Research Team
A
Alix Frischknecht
V
Viola Grünenfelder
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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