Minimally Invasive Atlantoaxial Lateral Mass Joint Fusion (MIS-PALF) As a Surgical Treatment of Atlantoaxial Dislocation

Официальное название

Randomized Controlled Study of Minimally Invasive Atlantoaxial Mass Fusion and Open Atlantoaxial Fusion in the Treatment of Atlantoaxial Dislocation

Обзор

The conventional treatment for atlantoaxial dislocation is atlantoaxial fixation and fusion using the Goel-Harms technique, which involves a midline incision, dissection of the occipital muscle group, and is associated with disadvantages such as damage to the posterior ligament and muscle, high incidence of postoperative occipital cervical pain, and significant blood loss due to intraoperative bleeding and postoperative drainage. Since 2013, various studies have reported minimally invasive posterior atlantoaxial lateral mass joint fusion techniques through muscle spaces, but previous studies were all case reports, without sufficient reliability and controlled studies. The Department of Orthopedics at Peking University Third Hospital has been using the minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion (Mis-PALF) technique for the treatment of atlantoaxial dislocation since 2015, with preliminary good clinical results. In order to further compare the advantages and disadvantages of the two surgical methods from a larger sample, a randomized controlled study is planned. The patients will be randomly divided into two groups, with the experimental group receiving the Mis-PALF surgery and the control group receiving open atlantoaxial fusion and fixation. There will be a 1-2 year follow-up to compare the safety and effectiveness of the two surgical methods for the treatment of atlantoaxial dislocation.

Вмешательства

• Процедура minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion
  Make a 4.5 cm incision along the median line and then dissect the trapezius, splenius capitis, and semispinalis capitis muscle laterally 1.5 cm off the median line. Retract the obliquus capitis inferior muscle to expose the C1-C2 intra-articular space. Remove the articular cartilage, insert allogenic granular bone and 3D-printed cage. Place the screws and rod in the same positions as conventional surgery, and the operation is completed.
• Процедура Open atlantoaxial fixation and fusion
  The Goel-Harms procedure will be used in the control group. Screws and rods are placed in the same position as in the experimental group, and a negative-pressure drain was placed until daily drainage was \<50 mL.

Первичные конечные точки

• Perioperative Blood Loss [Срок оценки: 2 weeks]
• Postoperative Stay [Срок оценки: 2 weeks]
• Level of Occipitocervical Pain [Срок оценки: 12 months]
• Main location of occipitocervical pain [Срок оценки: 12 months]
• Painkillers Used for Occipitocervical Pain [Срок оценки: 12 months]

Вторичные конечные точки (5)

• Incidence of Adverse Events [Срок оценки: 12 months]
• Atlantoaxial Reduction Rate [Срок оценки: 12 months]
• Bone Graft Fusion Rate [Срок оценки: 12 months]
• Improvement Rate of Quality of Life [Срок оценки: 12 months]
• Improvement of Neurological Function [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age range from 0 to 80 years old, regardless of gender
• Diagnosed with atlantoaxial dislocation, suitable for posterior surgical treatment
• Index of assessment integrity
• Agree to participate in the study and sign the informed consent

Критерии исключения

• Atlantoaxial dislocation without surgical treatment
• Atlantoaxial dislocation treated by other operation, such as TARP

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT06678711 · M2024730

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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