Conservative Treatment for Atlantoaxial Dislocation Patients Without Neurological Deficit

Not yet recruiting

• Conditions: Atlantoaxial Dislocation

• Registration Number: NCT06772311
• Lead Sponsor: Peking University Third Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-01
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-01-15
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of neurological deficit	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 Outcome Measures

Name	Time	Method
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.	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 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.	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	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.	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.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China