A Study on Diagnosis and Treatment Strategies for Atlantoaxial Dislocation

Treatment Clinical Trial

Official title:

A Study on Diagnosis and Treatment Strategies for Atlantoaxial Dislocation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233539
• Other study ID #: M2022822
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with atlantoaxial dislocation and treated with surgery

Exclusion Criteria:

• Disagree to participate in this study.

Related Conditions & MeSH terms

• Diagnostic
• Treatment

Intervention

Other:
• Observational research without intervention
Observational research without intervention

Locations

Country	Name	City	State
China	Shenglin Wang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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