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Идёт набор NCT05538416

Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion

Наблюдательное Degenerative Spondylolisthesis Spondylolytic Spondylolisthesis

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: Posterior Lumbar Interbody Fusion (PLIF).
Кому может быть актуально
Состояния в реестре: Degenerative Spondylolisthesis, Spondylolytic Spondylolisthesis. Базовые параметры: 18 лет — 75 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
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

A combined prospective cohort study and retrospective analysis of previously collected data. Three different techniques for posterior lumbar interbody fusion (PLIF) are compared: CBT-PLIF, MI-PLIF and open PLIF. A total of 180 patients are included, who will be followed up to 6 weeks postoperatively.

Подробное описание

A combined prospective cohort study for CBT-PLIF and retrospective analysis of prospectively collected data from the MISOS study, regarding traditional open PLIF and MI-PLIF. A total of 180 patients will be included in the study: 60 prospective CBT-PLIF patients, 60 retrospective open PLIF patients and 60 retrospective MI-PLIF patients.

The new data will be collected prospectively by means of questionnaires. No biomaterial will be collected. The included patients will be asked to complete questionnaires before surgery, 2 and 6 weeks after surgery. In addition, VAS scores will be noted throughout the hospital stay, 2 and 6 weeks after surgery.

Inclusion criteria: Patients aged 18-75 years with neurogenic claudication and/or radicular leg pain due to low-grade (Meyerding grades l and ll) degenerative or spondylolytic spondylolisthesis with persistent symptoms for more than 3 months.

Exclusion criteria: previous spinal fusion surgery at the same level, osteoporosis (only when using bisphosphonate), active infection or previous infection at the surgical site, active cancer, spondylolisthesis grade III or greater, more than one symptomatic level requiring fusion, pregnancy, contraindication to surgery, severe mental or psychiatric disorder, substance abuse, insufficient knowledge of the Dutch language and morbid obesity (body mass index \>40).

Main research question: Does the CBT-PLIF provide less low back pain in the short term than the traditional open PLIF and the MI-PLIF?

Primary outcome measure

* Low back pain measured with the Visual Analogue Scale (VAS) 2 weeks after surgery Secondary Outcomes * Low back pain during hospitalization (measured every day), 2 and 6 weeks after surgery * Leg pain * Oswestry Disability Index * Quality of life (EQ-5D-5L) * Observed patient recovery * Other parameters such as complications, surgical parameters (intraoperative blood loss, duration of surgery), length of stay in hospital and return to work

Вмешательства

  • Процедура Posterior Lumbar Interbody Fusion (PLIF)
    Spinal fusion in the lumbar spine by inserting a cage directly into the disc space. This is an observational study in which the standard procedure/care is followed.

Первичные конечные точки

  • VAS low back pain [Срок оценки: 2 weeks postoperative]
Вторичные конечные точки (5)
  • VAS low back pain [Срок оценки: During hospital stay, measured each day and 6 weeks postoperative]
  • VAS leg pain [Срок оценки: During hospital stay, measured each day, 2 and 6 weeks postoperative]
  • Oswestry Disability Index [Срок оценки: 2 and 6 weeks postoperative]
  • Quality of Life (QoL) [Срок оценки: 2 and 6 weeks postoperative]
  • Perceived recovery of the patient [Срок оценки: 2 and 6 weeks postoperative]

Критерии участия

Критерии включения

  • 18-75 years
  • Degenerative or spondylolytic spondylolisthesis
  • Neurogenic claudication and/or radicular leg pain
  • Low grade (Meyerding grade l and ll)
  • Persistent complaints for over 3 months

Критерии исключения

  • Previous spine fusion surgery at the same level
  • Osteoporosis
  • Active infection or prior infection at the surgical site
  • Active cancer
  • Spondylolisthesis grade lll or greater
  • More than one symptomatic level that needs fusion
  • Pregnancy
  • Contraindication for surgery
  • Severe mental or psychiatric disorder
  • Substance abuse
  • Inadequate knowledge of Dutch language
  • Morbid obesity (body mass index >40)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • UMCG — Groningen

Идентификаторы

NCT: NCT05538416 · UMCG202200129

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗