A Study on Diagnosis and Treatment Strategies for Atlantoaxial Dislocation

NCT06233539 | Recruiting

• 1 other identifier: M2022822
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

The most effective treatment for atlantoaxial dislocation is surgical treatment, with the principle of achieving reduction, reconstruction, and fusion of the atlantoaxial joint. The surgical strategies mainly include simple anterior approach, simple posterior approach, and combined anterior posterior approach. The investigators have summarized 904 cases of atlantoaxial instability or dislocation from 1998 to 2010 and preliminarily published the diagnosis and treatment strategy tree of the Third Hospital of Beijing Medical University. This strategy is divided into four types based on the severity of atlantoaxial dislocation: unstable, reversible, difficult to recover, and skeletal, and enters different surgical treatment processes. With the increase in the number of cases, accumulation of experience, and technological improvements in the past decade, spinal surgery colleagues have updated their classification diagnosis, diagnosis and treatment processes, and surgical techniques for atlantoaxial instability or dislocation. However, the selection of treatment strategies for atlantoaxial dislocation is mostly based on the surgeon's own experience, and there is a lack of standardized, large-scale, and high-level evidence-based medical research on the safety and effectiveness of current empirical strategies. Based on this, this study intends to adopt a multicenter, retrospective, and prospective study to construct a high-quality clinical cohort of atlantoaxial dislocation, update the classification and diagnosis and treatment strategies of atlantoaxial dislocation. And conduct long-term follow-up on patients to evaluate their safety and effectiveness, guide the surgical treatment of atlantoaxial dislocation, and thus form a recognized diagnostic and treatment standard for atlantoaxial dislocation.

Conditions

Atlantoaxial Dislocation; Treatment; Diagnostic

Outcome Measures

Primary Outcomes (1)

• The incidence of special attention adverse events in patients within 12 months after surgery

  The proportion of adverse events occurring in patients during the study period to the total number of study patients. Recording and reporting of adverse events, including: • deterioration of neurological function * Incision infection * Vascular injury Airway obstruction Poor reset • Unplanned readmission and unplanned reoperation • Internal fixation failure Fusion failure Surgical related lower cervical spine deformities

  12 month follow up

Study Arms (2)

Retrospective section

Other: Observational research without intervention

Prospective section

Other: Observational research without intervention

Interventions

Observational research without intervention OTHER

Observational research without intervention

Prospective section; Retrospective section

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with atlantoaxial dislocation and treated with surgery

You may qualify if:

• Patients diagnosed with atlantoaxial dislocation and treated with surgery

You may not qualify if:

• Disagree to participate in this study.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Shenglin Wang

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Disease

Interventions

Methods

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: December 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 3, 2024

Record last verified: 2024-01

Locations

CN (1)