Clinical trial NCT05847270: Surgical Treatment of Irreducible Atlantoaxial Dislocation
Official title: A Randomized Controlled Study for Surgical Treatment of Irreducible Atlantoaxial Dislocation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irreducible Atlantoaxial Dislocation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Xuanwu Hospital, Beijing
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Second Affiliated Hospital of Wenzhou Medical University
name: Tianjin People's Hospital
name: First Affiliated Hospital of Kunming Medical University
First posted: 2023-05-06
Enrollment: 70
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complete Decompression Rate
timeFrame: 12 months
measure: Bone Graft Fusion Rate
timeFrame: 12 months
measure: Atlantoaxial Reduction Rate
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of Adverse Events (12 Months After Surgery)
timeFrame: 12 months
measure: Improvement Rate of Quality of Life (12 Months After Surgery)
timeFrame: 12 months
measure: Improvement of Neurological Function
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: