Minimally Invasive Atlantoaxial Lateral Mass Joint Fusion (MIS-PALF) As a Surgical Treatment of Atlantoaxial Dislocation
- Conditions
- Atlantoaxial Dislocation
- Registration Number
- NCT06678711
- Lead Sponsor
- Peking University Third Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- Atlantoaxial dislocation without surgical treatment
- Atlantoaxial dislocation treated by other operation, such as TARP
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
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.
- Secondary Outcome Measures
Name Time Method Incidence of Adverse Events 12 months This metric is defined as the proportion of adverse events that manifest during the study's duration relative to the total number of patients enrolled. Adverse events encompass a range of critical factors, including but not limited to: Neurological deterioration, Incision infection, Vascular injury, Airway obstruction, Poor reduction, Unplanned readmission and re-surgery, Internal fixation failure, Fusion failure, Surgical-related lower cervical spine deformities.
Atlantoaxial Reduction Rate 12 months To gauge the effectiveness of the surgical interventions in achieving atlantoaxial reduction, postoperative CT scans of the head and neck will be conducted. Measurements will be taken of the distance between the odontoid process and key reference lines, including Chamberlain's line (CL), Wackenheim line (WL), McRae line (ML), and atlantodental interval (ADI). The reduction rate will be calculated by comparing the postoperative measurements to the preoperative values, expressed as a ratio.
Bone Graft Fusion Rate 12 months Evaluation of the proportion of patients exhibiting successful bone fusion between the atlas and axis will be conducted through postoperative three-dimensional CT examinations of the cervical spine. The bone graft fusion rate will be determined by calculating the number of patients with evident fusion relative to the total number of patients enrolled.
Improvement Rate of Quality of Life 12 months The quality of life for each patient will be assessed using the Short Form 12-Item(SF-12) Health Survey. SF-12 scores ranges from 0 to 100, and 100 usually means healthier in a certain dimension. The improvement rate in quality of life will be calculated based on the preoperative and postoperative differences in SF-12 scores. This indicator offers insights into the impact of surgical interventions on patients' overall well-being and quality of life, providing a vital perspective on treatment effectiveness.
Improvement of Neurological Function 12 months To assess the extent of neurological function improvement, patients' Japanese Orthopaedic Association(JOA) scores one year after surgery will be compared with their preoperative scores. JOA score ranges form 0 to 17, and 0 means worse neurological function. The JOA improvement rate will be calculated based on the cervical JOA score, employing the Hirabayashi method formula: JOA Improvement Rate = (Postoperative JOA Score - Preoperative JOA Score) / (17 - Preoperative JOA Score) \* 100%.
Trial Locations
- Locations (1)
Peking University Third Hospital
🇨🇳Beijing, Beijing, China