Conservative Treatment for Atlantoaxial Dislocation Patients Without Neurological Deficit

NCT06772311 | Not Yet Recruiting DMC

• 1 other identifier: M20248745
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Atlantoaxial Dislocation

Outcome Measures

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.

  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 (3)

• 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.

Study Arms (2)

Conservative Treatment Group

Patients who declined surgery and request conservative treatment and observation.

Surgical Intervention Group

Patients who request surgical intervention.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Atlantoaxial dislocation patients without neurological deficit.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• 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
• Affiliated hospital of Guilin medical university,China: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

No samples will be retained.

Central Study Contacts

Shenglin Wang, M.D.

CONTACT

+8613501380281; pkuwsl@126.com

Zhihang Gan, M.B.

CONTACT

+8618786004556; 2010301328@stu.pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 13, 2025
• Study Start: January 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)