About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patients meet the diagnostic criteria for atlantoaxial dislocation, that is, the ADI exceeds the normal range: it is over 3 mm in adults and over 5 mm in children.
The patients have no clinical manifestations of the nervous system, including occipital neuralgia, manifestations of cranial nerve impairment (such as dysphagia, dysarthria, nystagmus, etc.) and manifestations of spinal cord impairment (such as unsteadiness in holding objects, unsteady gait, decreased limb muscle strength, etc.).
After fully understanding their own conditions as well as the advantages, disadvantages and risks of both conservative treatment and surgical treatment, the patients can choose the initial treatment method on their own. If they choose conservative treatment, they will be included in the conservative treatment. If they choose surgical treatment, they will be included in the surgical intervention group.
Disqualifiers
Patients who have undergone surgeries in the cranio-cervical junction previously.
Patients with infections or tumors in the cranio-cervical junction.
Patients with fresh fractures in the cranio-cervical junction.
Patients with clinical manifestations of nerve deficit.
Trial population
Atlantoaxial dislocation patients without neurological deficit.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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Peking University Third Hospital
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborator
Shanxi Medical University Second Hospital
Collaborator
Sir Run Run Shaw Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Hebei Medical University Third Hospital
Collaborator
Shanxi Bethune Hospital
Collaborator
Daping Hospital of Army Medical University
Collaborator
Shengjing Hospital
Collaborator
Tianjin People's Hospital
Collaborator
First Affiliated Hospital of Kunming Medical University
Collaborator
Guilin Medical University, China
Collaborator
This trial is not recruiting at the moment. You can still explore other options: