Surgical Treatment of Irreducible Atlantoaxial Dislocation

NCT05847270 | Recruiting

• 1 other identifier: M2023203
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Irreducible Atlantoaxial Dislocation

Outcome Measures

Primary Outcomes (3)

• Complete Decompression Rate

  Effective spinal cord decompression on MRI, and the arachnoid space between the spinal cord and the odontoid process can reappear.

  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

• 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

Secondary Outcomes (3)

• Incidence of Adverse Events (12 Months After Surgery)

  12 months

• Improvement Rate of Quality of Life (12 Months After Surgery)

  12 months

• Improvement of Neurological Function

  12 months

Study Arms (2)

Anterior and posterior treatment strategy

EXPERIMENTAL

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

Procedure: Anterior and posterior treatment strategy

Simple Posterior Approach Treatment Strategy

EXPERIMENTAL

posterior reduction and internal fixation

Procedure: Simple posterior approach treatment strategy

Interventions

Anterior and posterior treatment strategy PROCEDURE

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.

Anterior and posterior treatment strategy

Simple posterior approach treatment strategy PROCEDURE

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.

Simple Posterior Approach Treatment Strategy

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible participants encompass individuals within the age range of 0 to 80 years, without regard to gender.
• 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.
• Participants who have provided informed consent either in person or through their legal representative (the principal).

You may not qualify if:

• 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.
• Critically ill patients, who are not suitable candidates for surgical intervention, will also be excluded.
• Patients who actively decline to participate in this research project will not be included in the study cohort.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Xuanwu Hospital, Beijing: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Tianjin People's Hospital: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Central Study Contacts

Shenglin Wang, MD

CONTACT

+86 13501380281; pkuwsl@126.com

Shilin Xue, MD

CONTACT

+86 18518982712; shilinx_pku@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 6, 2023
• Study Start: July 11, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 8, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)