NCT05876611

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 22, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

May 17, 2023

Last Update Submit

September 20, 2023

Conditions

Atlantoaxial Dislocation

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

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 other fusion systems

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

Interventions

New type of self stabilizing atlantoaxial fusion cageDEVICE

Using the above-mentioned new fusion cage for the treatment of atlantoaxial dislocation

Using the new type of self stabilizing atlantoaxial fusion cage

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with atlantoaxial dislocation

You may qualify if:

  • Atlantoaxial dislocation
  • Agree to use a new self stabilizing atlantoaxial fusion cage for surgery where feasible
  • Sign an informed consent form;

You may not qualify if:

  • Atlantoaxial dislocation without surgical treatment
  • Patients who refuse to participate in this project

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2023

First Posted

May 25, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2025

Study Completion

December 31, 2025

Last Updated

September 22, 2023

Record last verified: 2023-05