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A Multicenter, Prospective, Randomized Controlled Trial Comparing Long- to Medium-Term Clinical Outcomes of Atlantoaxial Lateral Mass Cage Implantation versus Traditional Autologous Bone Grafting in Patients with Atlantoaxial Dislocation

A Multicenter, Prospective, Randomized Controlled Trial Comparing Long- to Medium-Term Clinical Outcomes of Atlantoaxial Lateral Mass Cage Implantation versus Traditional Autologous Bone Grafting in Patients with Atlantoaxial Dislocation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125384
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atlantoaxial instability

Interventions

Cage Group:Atlantoaxial Lateral Mass Cage
Autologous Bone Group:Autologous Bone Grafting

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of atlantoaxial dislocation (preoperative dynamic X-ray indicates an atlantodental interval >3 mm). 2. Patients present with symptoms and signs of spinal cord or nerve root compression, such as numbness and weakness in the limbs, unsteady gait, or a girdle sensation, which may be accompanied by symptoms of spinal cord compression like bladder and bowel dysfunction, and for whom conservative treatment has been ineffective or symptoms are progressively worsening. 3. Patients without symptoms of nerve compression but with a clear diagnosis of atlantoaxial dislocation and evident atlantoaxial instability, who are at risk of severe complications such as paralysis from minor trauma. 4. Scheduled to undergo posterior atlantoaxial distraction reduction surgery, and the subject (or their legal guardian) is capable of providing written informed consent. 5. The patient is aged between 18 and 70 years old, with no gender restrictions.

Exclusion criteria

Exclusion criteria: 1. Cervical spondylosis (including but not limited to radiculopathy, myelopathy, cervical spinal stenosis), neurovascular malformations related to the cervical spine, ossification of cervical ligaments, trauma, tumors, inflammatory diseases such as tuberculosis, etc. 2. Concurrent spinal diseases in other regions (e.g., thoracic or lumbar spine) that affect the patient's clinical symptoms; presence of motor neuron diseases such as amyotrophic lateral sclerosis or other neurological disorders. 3. Participation in any other clinical trial within the past 3 months. 4. Comorbid psychiatric disorders, or cognitive impairment in the patient (or their legal guardian) that prevents the provision of fully informed consent. 5. Poor general physical condition rendering the patient unable to tolerate surgery; or preoperative evaluation deeming the patient unsuitable for surgical intervention. 6. Patients with poor cardiopulmonary function or advanced tumors; 7. Women who are pregnant, breastfeeding, or planning to become pregnant in the near future.

Design outcomes

Primary

MeasureTime frame
Horizontal Reduction Rate;Atlantoaxial Fusion Rate;Vertical Reduction Loss;

Secondary

MeasureTime frame
The Short-From-36 Health Survey, SF-36 ;Cervical JOA (C-JOA) Score Recovery Rate;Visual Analogue Scale (VAS) Score;

Countries

China

Contacts

Public ContactFuzhi Ai

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

aifzh@mail.sysu.edu.cn+86 20 81332523

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026