Duurzaamheid van leverancier Rod-constructies - aanvullende staaftechniek voor posterieure geïnstrumenteerde spinale fusies met lange segmenten
Duurzaamheid van aanvullende staafconstructies – aanvullende staaftechniek (SMART) – voor posterieure geïnstrumenteerde spinale fusieprocedures met lange segmenten: een retrospectief vergelijkend onderzoek in meerdere centra met constructies met dubbele staaf
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Viola Grünenfelder
- Telefoonnummer: +41 79 696 33 97
- E-mail: viola.gruenenfelder@aofoundation.org
Studie Contact Back-up
- Naam: Alix Frischknecht
- Telefoonnummer: +41 79 606 41 48
- E-mail: alix.frischknecht@aofoundation.org
Studie Locaties
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Calgary, Canada, T2N 2T9
- Werving
- University of Calgary Spine
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Contact:
- Ganesh Swamy
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Toronto, Canada, M5T 2S8
- Werving
- University of Toronto
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Contact:
- Stephen Lewis
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Contact:
- Christopher Nielsen
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Hong Kong, China
- Voltooid
- Duchess of Kent Children's Hospital
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Kolkata, Indië
- Werving
- Kothari Medical Centre
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Contact:
- Saumayajit Basu, MD
- E-mail: saumyajitbasu@hotmail.com
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Hamamatsu, Japan, 431-3192
- Voltooid
- Hamamatsu University School of Medicine
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Tokyo, Japan, 113-8654
- Werving
- University of Tokyo
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Contact:
- So Kato, Prof
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Barcelona, Spanje, 08035
- Werving
- Hospital Vall d´Hebron
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Contact:
- Ferran Pellisé, MD
- E-mail: 24361fpu@comb.es
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Istanbul, Turkije (Türkiye)
- Werving
- Acibadem Maslak Hospital
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Contact:
- Caglar Yilgor, MD
- E-mail: caglaryilgor@gmail.com
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Contact:
- Ahmet Alanay
- E-mail: aalanay@gmail.com
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California
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Redwood City, California, Verenigde Staten, 94588
- Werving
- Stanford Spine Clinic
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Contact:
- Serena Hu, MD
- E-mail: shu3@stanford.edu
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Sacramento, California, Verenigde Staten, 95819
- Werving
- University of California
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Contact:
- Yashar Javidan
- E-mail: yjavidan@ucdavis.edu
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San Francisco, California, Verenigde Staten, 94144
- Beëindigd
- UCSF Spine Center
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21287
- Werving
- John Hopkis Hospital
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Contact:
- Khaled Kebaish
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55454
- Werving
- University of Minnesota Medical Center
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Contact:
- David Polly, MD
- E-mail: pollydw@umn.edu
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Missouri
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St Louis, Missouri, Verenigde Staten, 63110
- Werving
- Washington University in St. Louis, School of Medicine
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Contact:
- Brian Neuman
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St Louis, Missouri, Verenigde Staten, 63310
- Voltooid
- Washington University in St. Louis, School of Medicine, Saint Louis, Missouri 63110
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New York
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New York, New York, Verenigde Staten, 10032
- Werving
- Columbia University / NYP Och Spine Hospital
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Contact:
- Zeeshan Sardar
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Virginia
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Charlottesville, Virginia, Verenigde Staten, 22908
- Werving
- University of Virginia
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Contact:
- Justin S Smith, MD, PhD
- Telefoonnummer: 434-243-6339
- E-mail: jss7f@virginia.edu
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Contact:
- Judith G Beenhakker
- E-mail: JGB3P@uvahealth.org
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Patients who underwent long-segment posterior thoracolumbar (TL) instrumented fusion
Beschrijving
Inclusion Criteria:
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Age 45 years and older.
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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.
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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.
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The index surgery was performed between January 1, 2014, and December 31, 2020, inclusive.
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Minimum 3 months of FU after the index surgery.
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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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: RETROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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 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 with either supplementary rod constructs or dual-rod constructs. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Rod fracture (RF)
Tijdsspanne: 2 years
|
Incidence of rod fracture(s) |
2 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to rod fracture
Tijdsspanne: 2 years
|
Time to the first rod fracture after index surgery |
2 years
|
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Time to rod fracture
Tijdsspanne: 10 years and 3 months
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Time to the first rod fracture after index surgery |
10 years and 3 months
|
|
Configurations of supplementary rod constructs
Tijdsspanne: Baseline
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Descriptions of configurations of supplementary rod constructs |
Baseline
|
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Treatment for rod fracture
Tijdsspanne: 10 years and 3 months
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Descriptions of different treatment strategies for rod fractures |
10 years and 3 months
|
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Recurrent RFs
Tijdsspanne: 10 years and 3 months
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Incidence of recurrent rod fractures |
10 years and 3 months
|
|
Other mechanical failures
Tijdsspanne: 10 years and 3 months
|
Other mechanical failures other than rod fractures |
10 years and 3 months
|
|
Surgical complications
Tijdsspanne: 10 years and 3 months
|
Selective surgical complications |
10 years and 3 months
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Justin S Smith, MD, PhD, Professor of Neurosurgery Chief of Spine Division, Fellowship Director University of Virginia
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- SMART
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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