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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Perioperative Blood Loss — 2 weeks
  Blood loss due to intraoperative bleeding and postoperative drainage.
• Postoperative Stay — 2 weeks
  The time from the completion of surgery to the patient leaving hospital.
• Level of Occipitocervical Pain — 12 months
  The level of patients' occipitocervical pain is described by Numerical Rating Scale, from zero to ten, and ten means the most pain.
• Main location of occipitocervical pain — 12 months
  The location of patients' occipitocervical pain is indicated by patients on a diagram illustrating the anatomical regions of the head and neck.
• Painkillers Used for Occipitocervical Pain — 12 months
  Patients are asked about whether they used any painkillers for occipitocervical pain and which painkillers they used.

Trial sites (1)

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