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

Launched by AO FOUNDATION, AO SPINE · Apr 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying different methods used in spinal fusion surgery, specifically looking at two types of rod constructs: the supplementary rod construct and the dual-rod construct. The goal is to understand how well these techniques work over time for patients who have had long-segment spinal fusions. Patients who are 45 years or older and have previously undergone this type of surgery between January 2014 and December 2020 may be eligible to participate. It's important that these patients received either a supplementary or dual-rod construct during their surgery and have at least three months of follow-up care after their procedure.

If you decide to participate in this study, your medical records will be reviewed to gather information about your surgery and recovery. This study is not currently recruiting participants, but it aims to help researchers learn more about the effectiveness and durability of these surgical techniques. Please note that certain conditions, such as recent trauma or specific diseases, may exclude individuals from participating. Your involvement could contribute to better understanding spinal fusion surgeries and improving patient care in the future.

Gender

ALL

Eligibility criteria

• 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.