Conservative Treatment for Atlantoaxial Dislocation Patients Without Neurological Deficit

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Atlantoaxial Dislocation

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Shenglin Wang, M.D.; Phone Number: +8613501380281; Email: pkuwsl@126.com
• Study Contact Backup: Name: Zhihang Gan, M.B.; Phone Number: +8618786004556; Email: 2010301328@stu.pku.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
      • Contact: Zhihang Gan, M.B.; Phone Number: +8618786004556; Email: 2010301328@stu.pku.edu.cn
      • Contact: Shenglin Wang, M.D.; Phone Number: +86 13501380281; Email: pkuwsl@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Atlantoaxial dislocation patients without neurological deficit.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Conservative Treatment Group; Patients who declined surgery and request conservative treatment and observation.
Surgical Intervention Group; Patients who request surgical intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Japanese Orthopaedic Association score	The Japanese Orthopaedic Association (JOA) score is a widely used disease-specific outcome tool that can provide a quantitative measure for patients with cervical myelopathy. JOA score consists of 6 domains: motor function in upper extremities, motor function in lower extremities, sensory function in upper extremities, sensory function in the trunk, sensory function in lower extremities, and bladder function, with a minimum total score of 0 and maximum of 17.	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 Neck Disability Index (NDI) is the most widely used assessment tool measuring disability due to neck pain or neck injury. The NDI consists of 10 items: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. The total score for the NDI is out of 50. A higher total score indicates a higher level of disability.	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	Atlantodental Interval (ADI) refers to the distance between the anterior tubercle of the atlas and the odontoid process, which reflects the severity of atlantoaxial dislocation.	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.

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Shengjing Hospital; The First Affiliated Hospital of Zhengzhou University; Sir Run Run Shaw Hospital; Hebei Medical University Third Hospital; Tianjin People's Hospital; Sun Yat-sen Memorial Hospital,Sun Yat-sen University; Shanxi Bethune Hospital; Daping Hospital of Army Medical University; First Affiliated Hospital of Kunming Medical University; Affiliated hospital of Guilin medical university,China; Shanxi Medical University Second Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 1, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Joint Dislocations
• Other Study ID Numbers: M20248745

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No