Conservative Treatment for Atlantoaxial Dislocation Patients Without Neurological Deficit

NCT ID: NCT06772311

Last Updated: 2025-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2030-12-31

Brief Summary

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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

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Conditions

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Atlantoaxial Dislocation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conservative Treatment Group

Patients who declined surgery and request conservative treatment and observation.

No interventions assigned to this group

Surgical Intervention Group

Patients who request surgical intervention.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Shanxi Medical University Second Hospital

UNKNOWN

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Hebei Medical University Third Hospital

OTHER

Sponsor Role collaborator

Shanxi Bethune Hospital

OTHER

Sponsor Role collaborator

Daping Hospital of Army Medical University

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Tianjin People's Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role collaborator

Affiliated hospital of Guilin medical university,China

UNKNOWN

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wang Shenglin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Shenglin Wang, M.D.

Role: CONTACT

+8613501380281

Zhihang Gan, M.B.

Role: CONTACT

+8618786004556

Facility Contacts

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Shenglin Wang, M.D.

Role: primary

+86 13501380281

Zhihang Gan, M.B.

Role: backup

+8618786004556

Other Identifiers

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M20248745

Identifier Type: -

Identifier Source: org_study_id

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