Atlantoaxial DislocationNCT05876611
Clinical Application of a Self Stabilizing Atlantoaxial Fusion Cage
An observational study of Atlantoaxial Dislocation, run by Peking University Third Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atlantoaxial Dislocation
- What is being tested?
- New type of self stabilizing atlantoaxial fusion cage
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with atlantoaxial dislocation
Who may be able to join
- Atlantoaxial dislocation
- Agree to use a new self stabilizing atlantoaxial fusion cage for surgery where feasible
- Sign an informed consent form;
Who cannot join
- Atlantoaxial dislocation without surgical treatment
- Patients who refuse to participate in this project
About this study
Official title: 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.
- Conditions
- Atlantoaxial Dislocation
- Being tested
- New type of self stabilizing atlantoaxial fusion cage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New type of self stabilizing atlantoaxial fusion cageDevice
Using the above-mentioned new fusion cage for the treatment of atlantoaxial dislocation
| Study group | Role | What they receive |
|---|---|---|
| Using the new type of self stabilizing atlantoaxial fusion cage | Use the new type of self stabilizing atlantoaxial fusion cage to treat atlantoaxial dislocation. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fusion rate
Postoperative atlantoaxial fusion conditions
Measured: 12 month follow up
neural functions
Postoperative neurological function recovery conditions
Measured: 12 month follow up
complications
Short or long-term postoperative complications
Measured: 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atlantoaxial DislocationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876611
- Sponsor's protocol ID
- ZL 2022 1 0362717.5
- Status last verified
- May 2023
- First submitted
- 17 May 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of a Self Stabilizing Atlantoaxial Fusion Cage: a Cohort Study
- ClinicalTrials.gov ID
- NCT05876611
- Acronym / sponsor ID
- ZL 2022 1 0362717.5
- Conditions
- Atlantoaxial Dislocation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using the new type of self stabilizing atlantoaxial fusion cage | – | Device: New type of self stabilizing atlantoaxial fusion cageUse 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with atlantoaxial dislocation
Key inclusion criteria (3 listed)
- Atlantoaxial dislocation
- Agree to use a new self stabilizing atlantoaxial fusion cage for surgery where feasible
- Sign an informed consent form;
Key exclusion criteria (2 listed)
- Atlantoaxial dislocation without surgical treatment
- Patients who refuse to participate in this project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New type of self stabilizing atlantoaxial fusion cageUsing the above-mentioned new fusion cage for the treatment of atlantoaxial dislocation | Device | Using the new type of self stabilizing atlantoaxial fusion cage |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atlantoaxial Dislocation, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fusion rate (time frame: 12 month follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.