An observational study in Atlantoaxial Dislocation, sponsored by Peking University Third Hospital. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-01-13.
Sponsored by Peking University Third Hospital · Observational
The goal of this observational study was to learn about the long-term clinical efficacy of conservative treatment in atlantoaxial dislocation patients without neurological deficit. The main question it aims to answer is:
Is surgical intervention always necessary in atlantoaxial dislocation patients without nerve deficit?
Patients who refuse surgical intervention will continue to be treated conservatively. Clinical outcomes will be summarized over five years of follow-up
Peking University Third Hospital is the lead sponsor of 749 studies on the registry; 270 are open to participants now.
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Atlantoaxial dislocation patients without neurological deficit.
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Exclusion Criteria:
Patients who declined surgery and request conservative treatment and observation.
Patients who request surgical intervention.
The incidence of neurological deficit
The incidence of neurological deficit is defined as the proportion of patients with neurological deficit to the total number of patients during the research period. Neurological deficit includes cranial nerve involvement and spinal cord involvement, with specific clinical manifestations such as occipital neuralgia, dysphagia, dysarthria, nystagmus, unsteadiness in holding objects, unsteady gait, decreased limb muscle strength, paralysis, and others.
Time frame: The incidence of neurological deficit will be assessed at the initial visit, and at 3 months, 6 months, and 12 months after the initial visit, with annual follow-ups thereafter. Follow-up will continue for at least 5 years.
Japanese Orthopaedic Association score
The Japanese Orthopaedic Association (JOA) score is a widely used disease-specific outcome tool that can provide a quantitative measure for patients with cervical myelopathy. JOA score consists of 6 domains: motor function in upper extremities, motor function in lower extremities, sensory function in upper extremities, sensory function in the trunk, sensory function in lower extremities, and bladder function, with a minimum total score of 0 and maximum of 17.
Time frame: The JOA score will be assessed at the initial visit, and at 3 months, 6 months, and 12 months after the initial visit, with annual follow-ups thereafter. Follow-up will continue for at least 5 years.
Neck Disability Index
The Neck Disability Index (NDI) is the most widely used assessment tool measuring disability due to neck pain or neck injury. The NDI consists of 10 items: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The total score for the NDI is out of 50. A higher total score indicates a higher level of disability.
Time frame: The NDI will be assessed at the initial visit, and at 3 months, 6 months, and 12 months after the initial visit, with annual follow-ups thereafter. Follow-up will continue for at least 5 years.
ADI
Atlantodental Interval (ADI) refers to the distance between the anterior tubercle of the atlas and the odontoid process, which reflects the severity of atlantoaxial dislocation.
Time frame: The ADI will be assessed at the initial visit, and at 3 months, 6 months, and 12 months after the initial visit, with annual follow-ups thereafter. Follow-up will continue for at least 5 years.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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