Clinical Efficacy of Surgical Vs. Conservative Treatment for Atlantoaxial Dislocation Patients Without Neurological Deficit: a Prospective, Multicenter, Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Atlantoaxial Dislocation
- Sponsor
- Peking University Third Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- The incidence of neurological deficit
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
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
Investigators
Wang Shenglin
Professor
Peking University Third Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
- •Patients with severe diseases in other spinal regions such as the thoracic and lumbar spine that affect their clinical symptoms; patients with motor neuron diseases like amyotrophic lateral sclerosis and other severe neurological diseases.
- •Patients who have participated in other clinical trials within the recent three months.
- •Patients with mental disorders whose cognitive impairments (or those of their legal guardians) prevent them from giving full informed consent.
- •Patients who refuse to participate in this study.
Outcomes
Primary Outcomes
The incidence of neurological deficit
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.
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 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 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(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.)