Clinical Application of a Self Stabilizing Atlantoaxial Fusion Cage

Overview

Conventional open surgery often requires extensive dissection of the muscle insertion points of the suboccipital muscle group during the insertion position and direction of the atlas axis screw, resulting in sustained postoperative occipital neck pain and movement dysfunction. In order to overcome the shortcomings of the prior art mentioned above, the present invention provides a self stabilizing fusion cage with a wing plate. During surgery, a thinner and smaller screw through the wing plate is used to achieve a secure connection between the atlas axis and the fusion cage. Due to the smaller screw size, the screw placement has higher safety. The purpose of this study is to compare the advantages of using this new fusion cage compared to traditional surgical instruments.

Full Title of Study: “Clinical Application of a Self Stabilizing Atlantoaxial Fusion Cage: a Cohort Study”

Study Type

• Study Type: Observational [Patient Registry]
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: June 1, 2025

Interventions

• Device: New type of self stabilizing atlantoaxial fusion cage
  • Using the above-mentioned new fusion cage for the treatment of atlantoaxial dislocation

Arms, Groups and Cohorts

• Using the new type of self stabilizing atlantoaxial fusion cage
  • Use the new type of self stabilizing atlantoaxial fusion cage to treat atlantoaxial dislocation.
• Using other fusion systems
  • Use screw and plate system or other existing models of fusion cages.

Clinical Trial Outcome Measures

Primary Measures

• fusion rate
  • Time Frame: 12 month follow up
  • Postoperative atlantoaxial fusion conditions
• neural functions
  • Time Frame: 12 month follow up
  • Postoperative neurological function recovery conditions
• complications
  • Time Frame: 12 month follow up
  • Short or long-term postoperative complications

Participating in This Clinical Trial

Inclusion Criteria

1. Atlantoaxial dislocation 2. Agree to use a new self stabilizing atlantoaxial fusion cage for surgery where feasible 3. Sign an informed consent form; Exclusion Criteria:

1. Atlantoaxial dislocation without surgical treatment 2. Patients who refuse to participate in this project

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Peking University Third Hospital
• Provider of Information About this Clinical Study
  • Sponsor