About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients who underwent long-segment posterior thoracolumbar (TL) instrumented fusion
Trial design
Cohort
Retrospective
Treatments tested in this trial
long-segment posterior TL instrumented fusion
Procedure/Surgerylong-segment posterior TL instrumented fusion with either supplementary rod constructs or dual-rod constructs.
Treatment groups
Trial outcomes
Primary outcomes
Rod fracture (RF)
Incidence of rod fracture(s)
Secondary outcomes
Time to rod fracture
Time to the first rod fracture after index surgery
Time to rod fracture
Time to the first rod fracture after index surgery
Configurations of supplementary rod constructs
Descriptions of configurations of supplementary rod constructs
Treatment for rod fracture
Descriptions of different treatment strategies for rod fractures
Sponsors and contacts
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