Conservative Treatment for Atlantoaxial Dislocation Patients Without Neurological Deficit

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking University Third Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Conservative Treatment Group
Group B: Surgical Intervention Group

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

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