NCT05847270

Surgical Treatment of Irreducible Atlantoaxial Dislocation

A Randomized Controlled Study for Surgical Treatment of Irreducible Atlantoaxial Dislocation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irreducible Atlantoaxial Dislocation

Interventions

Type	Name	Description
PROCEDURE	Anterior and posterior treatment strategy	Before surgery, a large weight traction of 1/6 body weight was used to determine the reversibility of atlantoaxial dislocation. After determining that it is difficult to restore the dislocation, a technique of anterior oral release and posterior fixation fusion was used for reduction, with sequential release of the longus colli and longus capitis, the anterior longitudinal ligament, the blitateral lateral mass joints, the contracted soft-tissue mass between the odotiod and the anterior C1 tubercle, and the peri-odontoid ligaments (i.e., the alar ligaments and the apical ligament), followed by posterior internal fixation and bone grafting was used between C1 and C2 lamina.
PROCEDURE	Simple posterior approach treatment strategy	Preceding the surgical procedure, an assessment was conducted utilizing 1/6 weight traction to ascertain the reducibility of atlantoaxial dislocation. Upon confirmation of IAAD, the chosen approach involved the utilization of a specially designed spreader, tailored to the patient's atlanto-axial joint morphology. Upon entering the joint space, the spreaders were skillfully maneuvered to gently open the joint through rotational and prying actions. Subsequently, two cages, pre-filled with autogenous bone grafts, and designed with the appropriate angle and height, were meticulously placed between the Atlanto-axial joints via a posterior approach. This procedure facilitated direct distraction and reduction of the dislocated joint. In the final step of the surgical process, stabilization was achieved by securing the atlas and axis with screws and rods. This surgical approach was selected to address the unique challenges posed by IAAD, with the aim of achieving optimal patient outcomes.

Timeline

• Start date: 2023-07-11
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2023-05-06
• Last updated: 2024-01-08

Locations

1 site across 1 country: China