Clinical Application of a Self Stabilizing Atlantoaxial Fusion Cage

Not yet recruiting

• Conditions: Atlantoaxial Dislocation
• Interventions: Device: New type of self stabilizing atlantoaxial fusion cage

• Registration Number: NCT05876611
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-17
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-25
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-22
• Study Start: 2023-10-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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;

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Using the new type of self stabilizing atlantoaxial fusion cage	New type of self stabilizing atlantoaxial fusion cage	Use the new type of self stabilizing atlantoaxial fusion cage to treat atlantoaxial dislocation.

Primary Outcome Measures

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