Surgical options for treating irreducible atlantoaxial dislocation

A Randomized Controlled Study for Surgical Treatment of Irreducible Atlantoaxial Dislocation

This study is testing two different surgical methods to see which one works better for people with a serious neck condition called irreducible atlantoaxial dislocation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: N/A to 80 Years
• Sex: All
• Sponsor: Peking University Third Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05847270 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of two surgical approaches for irreducible atlantoaxial dislocation (IAAD): a simple posterior approach and a combined anterior and posterior approach. The study will involve 260 patients who will be randomly assigned to one of the two surgical groups. Comprehensive assessments will be conducted, including radiological evaluations and tracking of neurological function improvements over a 12-month follow-up period. The goal is to determine the optimal surgical strategy for managing IAAD and to establish diagnostic and treatment standards.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 0 to 80 years diagnosed with irreducible atlantoaxial dislocation who are eligible for surgical intervention.

Not a fit: Patients with significant comorbidities, critically ill conditions, or those who decline participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and standardized treatment protocols for patients with irreducible atlantoaxial dislocation.

How similar studies have performed: While there is ongoing debate regarding surgical approaches for IAAD, this study aims to provide high-level evidence that may clarify the optimal treatment strategy, making it a potentially novel contribution to the field.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Third Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Shenglin Wang, MD

Conditions: Irreducible Atlantoaxial Dislocation