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Набор скоро начнётся NCT06757816

Outcome of Accessory Rods and Ilic Fixation for Distal Augmentation of S1 Fixation

Без фазы С лечением Lumbosacral

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: accessory rod and iliac fixation for distal augmentation for S1 fixation..
Кому может быть актуально
Состояния в реестре: Lumbosacral. Базовые параметры: 15 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

To assess radiological and clinical outcome of use of accessory rod and iliac fixation for distal augmentation of L1 fixation

Подробное описание

Lumbar fusion is a surgical procedure that can be utilized to treat a variety of painful and degenerative conditions in the lower back. The most common conditions that indicate the need for an L5 S1 fusion include low back disc degeneration (also known as spondylolisthesis), spinal fractures, recurrent disc herniation, scoliosis, lumbar canal stenosis, and instability resulting from failed spine surgery . The success rate of lumbo sacral fusion surgery is influenced by many factors. These include non-union, hardware breakage or loosening, discitis, osteoporosis, tumors, and pseudoarthrosis . Lumbosacral pseudarthrosis is one of the most common complications in L5 S1 fusion surgery. It is a strong indication for revision surgery if severe symptoms persist. The rate of pseudarthrosis increases based on several parameters, including the number of levels fused, the type of fusion, and medical risk factors for pseudarthrosis .

There are various methods of revision. One such method involves the use of iliac screws in addition to lumbo sacral interbody fusion. This approach improves the outcomes of revision fusion surgery but still carries the risk of rod breakage . S2 alar-iliac (S2AI) screws have been described as another method, but they have some disadvantages like rod breakage, screw misplacement, breach of cortical bone, and injury to neurovascular structures. These structures include superior gluteal vessels, external iliac vessels, pudendal vessels, superior gluteal nerves, sciatic nerve, and sympathetic chain ganglia . Our theory proposes the use of an accessory rod, which offers the advantage of dual rod fixation with a low incidence of rod breakage. We also suggest the free-handed placement of the iliac screw in the iliac bone, which plays a significant role in improving the integrity of the fixation and simplifies the application process.

Multiple-rod constructs could prevent rod breakage and pseudarthrosis while also lowering the revision rate. As a result, they could lead to a better clinical outcome than the 2-rod construct. This approach is based on the principle that increasing the number of rods in the construct can distribute the load more evenly, reducing the risk of rod breakage and pseudarthrosis. This, in turn, could lead to a lower revision rate and better clinical outcomes

Вмешательства

  • Процедура accessory rod and iliac fixation for distal augmentation for S1 fixation.
    patients who were admitted to the spine unit and needed extension of fixation for L5 S1 fusion due to failed previous surgery, instability, or degenerative changes ,infection, tumors and pseudoarthrosis.

Первичные конечные точки

  • Outcome of accessory rod and iliac fixation for distal augmentation of S1 fixation [Срок оценки: 3 months post-operative: Initial assessment of the union. 1 year post-operative: Follow-up to confirm sustained union and assess long-term outcomes.]
Вторичные конечные точки (1)
  • Pain Relief [Срок оценки: Preoperative: VAS scores will be recorded before the surgery. Immediate Postoperative: VAS scores will be recorded immediately after the surgery. 3 Months Postoperative: VAS scores will be recorded to evaluate changes in pain intensity.]

Критерии участия

Критерии включения

  • The study will include all patients who were admitted to the spine unit and needed extension of fixation for L5 S1 fusion due to failed previous surgery, instability, or degenerative changes ,infection, tumors and pseudoarthrosis.

Критерии исключения

  • The study excludes patients who are less than 18 years and more than 90 years

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Assiut University — Asyut

Публикации

  • Thomson S. Failed back surgery syndrome - definition, epidemiology and demographics. Br J Pain. 2013 Feb;7(1):56-9. doi: 10.1177/2049463713479096. PMID 26516498
  • Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8. PMID 2071615
  • Chakravarty A. A survey of attitude of frontline clinicians and nurses towards adverse events. Med J Armed Forces India. 2013 Oct;69(4):335-40. doi: 10.1016/j.mjafi.2013.01.009. Epub 2013 May 9. PMID 24600139
  • Gill K, Blumenthal SL. Functional results after anterior lumbar fusion at L5-S1 in patients with normal and abnormal MRI scans. Spine (Phila Pa 1976). 1992 Aug;17(8):940-2. doi: 10.1097/00007632-199208000-00012. PMID 1387975

Идентификаторы

NCT: NCT06757816 · accessory rods and iliac screw

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗