Conservative Treatment for Atlantoaxial Dislocation Patients Without Neurological Deficit

Официальное название

Clinical Efficacy of Surgical Vs. Conservative Treatment for Atlantoaxial Dislocation Patients Without Neurological Deficit: a Prospective, Multicenter, Observational Study

Обзор

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

Первичные конечные точки

• The incidence of neurological deficit [Срок оценки: 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.]

Вторичные конечные точки (3)

• Japanese Orthopaedic Association score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT06772311 · M20248745

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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