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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atlantoaxial Dislocation
• Intervention / Treatment: Procedure: minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion; Procedure: Open atlantoaxial fixation and fusion

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shenglin Wang, MD; Phone Number: +86 13501380281; Email: pkuwsl@126.com
• Study Contact Backup: Name: Qiyue Gao, MD; Phone Number: +86 13811631230; Email: x2455960615@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
      • Contact: Shenglin Wang, MD; Phone Number: +86 13501380281; Email: pkuwsl@126.com
      • Contact: Qiyue Gao, MD; Phone Number: +86 13811631230; Email: x2455960615@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Minimal invasive surgery arm; Patients in minimal invasive surgery arm will receive minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion.	Procedure: 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.
Active Comparator: Open atlantoaxial fixation and fusion arm; Patients in open atlantoaxial fixation and fusion arm will receive atlantoaxial fixation and fusion using the Goel-Harms technique.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atlantoaxial Reduction Rate	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.	12 months
Bone Graft Fusion Rate	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.	12 months
Incidence of Adverse Events	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.	12 months
Improvement Rate of Quality of Life	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.	12 months
Improvement of Neurological Function	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%.	12 months

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University; Second Affiliated Hospital of Wenzhou Medical University; Hebei Medical University Third Hospital; Tianjin People's Hospital; Shanxi Bethune Hospital; Daping Hospital of Army Medical University; First Affiliated Hospital of Kunming Medical University; Shengjing hospital affiliated to China Medical University; Third Bethune Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): November 4, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 2, 2024
• First Submitted That Met QC Criteria: November 5, 2024
• First Posted (Estimated): November 7, 2024

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: minimal invasive surgery; atlantoaxial dislocation; MIS-PALF
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Joint Dislocations
• Other Study ID Numbers: M2024730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No