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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-80
SponsorPeking University Third Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Atlantoaxial dislocation without surgical treatment

Atlantoaxial dislocation treated by other operation, such as TARP

Trial design

Treatments tested in this trial

  • minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion
  • Open atlantoaxial fixation and fusion

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Peking University Third Hospital

Lead sponsor

Hebei Medical University Third Hospital

Collaborator

Shanxi Bethune Hospital

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborator

Second Affiliated Hospital of Wenzhou Medical University

Collaborator

Tianjin People's Hospital

Collaborator

First Affiliated Hospital of Kunming Medical University

Collaborator

Daping Hospital of Army Medical University

Collaborator

Shengjing Hospital

Collaborator

Third Bethune Hospital of Jilin University

Collaborator