Clinical Application of a Self Stabilizing Atlantoaxial Fusion Cage

Clinical Application of a Self Stabilizing Atlantoaxial Fusion Cage: a Cohort Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atlantoaxial Dislocation
• Intervention / Treatment: Device: New type of self stabilizing atlantoaxial fusion cage

• Study Type: Observational
• Enrollment (Estimated): 400

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with atlantoaxial dislocation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Using the new type of self stabilizing atlantoaxial fusion cage; Use the new type of self stabilizing atlantoaxial fusion cage to treat atlantoaxial dislocation.	Device: New type of self stabilizing atlantoaxial fusion cage; Using the above-mentioned new fusion cage for the treatment of atlantoaxial dislocation
Using other fusion systems; Use screw and plate system or other existing models of fusion cages.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ZL 2022 1 0362717.5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No