Clinical trial NCT06772311: Conservative Treatment for Atlantoaxial Dislocation Patients Without Neurological Deficit
Official title: Clinical Efficacy of Surgical Vs. Conservative Treatment for Atlantoaxial Dislocation Patients Without Neurological Deficit: a Prospective, Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atlantoaxial Dislocation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Zhengzhou University
name: Shanxi Medical University Second Hospital
name: Sir Run Run Shaw Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Hebei Medical University Third Hospital
name: Shanxi Bethune Hospital
name: Daping Hospital of Army Medical University
name: Shengjing Hospital
name: Tianjin People's Hospital
name: First Affiliated Hospital of Kunming Medical University
name: Affiliated hospital of Guilin medical university,China
First posted: 2025-01-13
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Atlantoaxial dislocation patients without neurological deficit.

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


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of neurological deficit
timeFrame: 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:
measure: Japanese Orthopaedic Association score
timeFrame: 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.
measure: Neck Disability Index
timeFrame: 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.
measure: ADI
timeFrame: 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:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: