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NCT Number: NCT06233539

A Study on Diagnosis and Treatment Strategies for Atlantoaxial Dislocation

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Shenglin Wang

Beijing, Beijing Municipality, 100191, China

Location status: Recruiting

Location contact

Shenglin Wang

CONTACT

[email protected]

+8613501380281

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with atlantoaxial dislocation and treated with surgery

Exclusion criteria

  • Disagree to participate in this study.

Treatment and study plan

Observational research without intervention

Other

Observational research without intervention

Primary outcomes

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

    Time frame: 12 month follow up

    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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 31, 2024
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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