Clinical trial NCT06678711: Minimally Invasive Atlantoaxial Lateral Mass Joint Fusion (MIS-PALF) As a Surgical Treatment of Atlantoaxial Dislocation
Official title: Randomized Controlled Study of Minimally Invasive Atlantoaxial Mass Fusion and Open Atlantoaxial Fusion in the Treatment of Atlantoaxial Dislocation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atlantoaxial Dislocation
Keywords: atlantoaxial dislocation
MIS-PALF
minimal invasive surgery
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Hebei Medical University Third Hospital
name: Shanxi Bethune Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Second Affiliated Hospital of Wenzhou Medical University
name: Tianjin People's Hospital
name: First Affiliated Hospital of Kunming Medical University
name: Daping Hospital of Army Medical University
name: Shengjing Hospital
name: Third Bethune Hospital of Jilin University
First posted: 2024-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Atlantoaxial dislocation without surgical treatment
2. Atlantoaxial dislocation treated by other operation, such as TARP

Primary outcomes:
measure: Perioperative Blood Loss
timeFrame: 2 weeks
measure: Postoperative Stay
timeFrame: 2 weeks
measure: Level of Occipitocervical Pain
timeFrame: 12 months
measure: Main location of occipitocervical pain
timeFrame: 12 months
measure: Painkillers Used for Occipitocervical Pain
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: 12 months
measure: Atlantoaxial Reduction Rate
timeFrame: 12 months
measure: Bone Graft Fusion Rate
timeFrame: 12 months
measure: Improvement Rate of Quality of Life
timeFrame: 12 months
measure: Improvement of Neurological Function
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: