Clinical Application of a Self Stabilizing Atlantoaxial Fusion Cage

Peking University

Status: Not yet enrolling

Conditions: Atlantoaxial Dislocation

Treatments: Device: New type of self stabilizing atlantoaxial fusion cage

Study type: Observational

Funder types: Other

Identifiers

NCT05876611

ZL 2022 1 0362717.5

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

Using the new type of self stabilizing atlantoaxial fusion cage

Description:

Use the new type of self stabilizing atlantoaxial fusion cage to treat atlantoaxial dislocation.

Treatment:

Device: New type of self stabilizing atlantoaxial fusion cage

Using other fusion systems

Description:

Use screw and plate system or other existing models of fusion cages.