Clinical trial NCT06368245: Durability of Suppl. Rod Constructs-SuppleMentAry Rod Technique for Long-segment Posterior Instrumented Spinal Fusions
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Fusion
Lead sponsor: AO Foundation, AO Spine
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 1244
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent long-segment posterior thoracolumbar (TL) instrumented fusion

Brief 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.

Detailed description: This multicenter retrospective comparative cohort study will enroll 1244 patients, who underwent primary or revision long-segment posterior thoracolumbar (TL) instrumented fusion using either a supplementary rod construct or a dual-rod construct. By comparing two groups of patients, ie, patients treated with supplementary rod constructs vs dual-rod constructs, in the setting of long-segment posterior instrumented spinal fusion, this study aims to provide quality evidence regarding the benefits of supplementary rod constructs in reducing the risk of RFs and other mechanical complications. This study shall provide the first long-term clinical evidence on clinical outcome and benefit of supplementary rod constructs.

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.

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.

Primary outcomes:
measure: Rod fracture (RF)
timeFrame: 2 years
Secondary outcomes:
measure: Time to rod fracture
timeFrame: 2 years
measure: Time to rod fracture
timeFrame: 10 years and 3 months
measure: Configurations of supplementary rod constructs
timeFrame: Baseline
measure: Treatment for rod fracture
timeFrame: 10 years and 3 months
measure: Recurrent RFs
timeFrame: 10 years and 3 months
measure: Other mechanical failures
timeFrame: 10 years and 3 months
measure: Surgical complications
timeFrame: 10 years and 3 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Spine Clinic
state: California
city: Sacramento
country: United States
facility: University of California
state: California
city: San Francisco
country: United States
facility: UCSF Spine Center
state: California
city: Baltimore
country: United States
facility: John Hopkis Hospital
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University in St. Louis, School of Medicine
state: Missouri
city: New York
country: United States
facility: Columbia University / NYP Och Spine Hospital
state: New York
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Calgary
country: Canada
facility: University of Calgary Spine
city: Toronto
country: Canada
facility: University of Toronto
city: Hong Kong
country: China
facility: Duchess of Kent Children's Hospital
city: Kolkata
country: India
facility: Kothari Medical Centre
city: Hamamatsu
country: Japan
facility: Hamamatsu University School of Medicine
city: Tokyo
country: Japan
facility: University of Tokyo
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
Study officials:
affiliation: Professor of Neurosurgery Chief of Spine Division, Fellowship Director University of Virginia
name: Justin S Smith, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: