Surgical Treatment of Irreducible Atlantoaxial Dislocation

Peking University

Status: Enrolling

Conditions: Irreducible Atlantoaxial Dislocation

Treatments: Procedure: Anterior and posterior treatment strategy; Procedure: Simple posterior approach treatment strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT05847270

M2023203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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).

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Anterior and posterior treatment strategy

Experimental group

Description:

Anterior transoral release and reduction + posterior internal fixation and bone graft fusion

Treatment:

Procedure: Anterior and posterior treatment strategy

Simple Posterior Approach Treatment Strategy

Experimental group

Description:

posterior reduction and internal fixation

Treatment:

Procedure: Simple posterior approach treatment strategy