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Conservative Treatment for Atlantoaxial Dislocation Patients Without Neurological Deficit

P

Peking University

Status

Not yet enrolling

Conditions

Atlantoaxial Dislocation

Study type

Observational

Funder types

Other

Identifiers

NCT06772311
M20248745

Details and patient eligibility

About

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

Enrollment

300 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Conservative Treatment Group
Description:
Patients who declined surgery and request conservative treatment and observation.
Surgical Intervention Group
Description:
Patients who request surgical intervention.

Trial contacts and locations

1

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Central trial contact

Shenglin Wang, M.D.; Zhihang Gan, M.B.

Data sourced from clinicaltrials.gov

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