Surgical Treatment of Irreducible Atlantoaxial Dislocation

Not Applicable

Recruiting

• Conditions: Irreducible Atlantoaxial Dislocation
• Interventions: Procedure: Anterior and posterior treatment strategy; Procedure: Simple posterior approach treatment strategy

• Registration Number: NCT05847270
• Lead Sponsor: Peking University Third Hospital

Brief Summary

At present, there is a lack of standardized, large-scale, and high-level evidence-based medicine research on the safety and effectiveness of treatment of irreducible atlantoaxial dislocation (IAAD).Based on this, the goal of this prospective randomized controlled study is to systematically investigate the optimal surgical approach (simple posterior approach and the combined anterior and posterior approach) for managing IAAD, providing insights into the most efficacious and safest course of action. And long-term follow-up will be conducted on patients to evaluate the safety and effectiveness of different surgical methods, and to develop diagnostic and treatment standards for irreducible atlantoaxial dislocation.

Detailed Description

The choice of surgical strategies for treating irreducible atlantoaxial dislocation (IAAD) is still a controversial topic. Surgical approaches under consideration of IAAD encompass the simple posterior approach and the combined anterior and posterior approach. The former offers procedural simplicity but has inherent limitations in the extent of reduction. In contrast, the latter approach holds the potential for a more comprehensive and reliable release and reduction. However, it also presents an elevated risk of infection and surgical complexity. The choice between these two strategies remains a controversy. Based on this, the goal of this prospective randomized controlled study is to systematically investigate the optimal surgical approach for managing IAAD, providing insights into the most efficacious and safest course of action.

Six high-level centers for the treatment of IAAD participated in this randomized controlled study. After rigorous sample size analysis, we plan to recruit 260 IAAD patients into two distinct trial groups: the "Simple Posterior Surgery Group" and the "Combined Anterior and Posterior Surgery Group". By analysing the comprehensive radiological assessment, the systematic tracking of neurological function improvement, meticulous evaluation of specific adverse events and a 12 month post-surgery follow-up we will systematically investigate the optimal surgical approach for managing IAAD.

Besides, this research endeavor has received full ethical clearance from the Peking University Third Hospital (PUTH) Medical Science Research Ethics Committee (IRB00006761-M2023203). All enrolled participants will provide informed consent voluntarily.

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-05-06
• Study Start: 2023-07-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-08
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Eligible participants encompass individuals within the age range of 0 to 80 years, without regard to gender.
2. Patients who have received a diagnosis of irreducible atlantoaxial dislocation (IAAD) based on preoperative imaging and skull traction evaluation, with a traction weight equivalent to 1/6 of their body weight following anesthesia. These patients are candidates for surgical intervention.
3. Participants who have provided informed consent either in person or through their legal representative (the principal).

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Exclusion Criteria

1. Individuals with concomitant medical conditions or diseases that significantly impact surgical treatment, such as malignant metastasis or infectious diseases, will be excluded from the study.
2. Critically ill patients, who are not suitable candidates for surgical intervention, will also be excluded.
3. Patients who actively decline to participate in this research project will not be included in the study cohort.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Anterior and posterior treatment strategy	Anterior and posterior treatment strategy	Anterior transoral release and reduction + posterior internal fixation and bone graft fusion
Simple Posterior Approach Treatment Strategy	Simple posterior approach treatment strategy	posterior reduction and internal fixation

Primary Outcome Measures

Name	Time	Method
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.
Complete Decompression Rate	12 months	Effective spinal cord decompression on MRI, and the arachnoid space between the spinal cord and the odontoid process can reappear.
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.

Secondary Outcome Measures

Name	Time	Method
Improvement Rate of Quality of Life (12 Months After Surgery)	12 months	The quality of life for each patient will be assessed using the SF-12 Health Survey. 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.
Incidence of Adverse Events (12 Months After Surgery)	12 months	The primary focus of evaluation is on the incidence of adverse events occurring within the 12-month post-surgery period. 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.
Improvement of Neurological Function	12 months	To assess the extent of neurological function improvement, patients' JOA scores one year after surgery will be compared with their preoperative scores. 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