Surgical Treatment of Irreducible Atlantoaxial Dislocation

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.

Conditions

• Irreducible Atlantoaxial Dislocation

Interventions

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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Tianjin People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Peking University Third Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SEQUENTIAL

Eligibility

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-11

Primary Completion

2025-12-31

Completion

2026-12-31

Countries

• China

Study Locations