Atlantoaxial DislocationNCT06003491
Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation
A study testing Intra-articular Cages in people with Atlantoaxial Dislocation, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The management of reducible atlantoaxial dislocation associated is challenging. Direct posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. In 2020, we modified this technique and proposed a posterior intra-articular distraction technique. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Atlantoaxial Dislocation
- What is being tested?
- Intra-articular Cages
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2024to Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CT indicated atlantoaxial dislocation Agree with the operation plan Agree to be followed up
Who cannot join
- The pathology is traumatic or RA Underwent operations in occipital-cervical region before With mortal diseases Without ability to sign papers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100032
zan chen, PHD, MD, +86 13911712120, chenzan66@163.com
About this study
Official title: A Randomized Controlled Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation
The management of reducible atlantoaxial dislocation associated is challenging. Direct posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. In 2020, we modified this technique and proposed a posterior intra-articular distraction technique. The intra-articular distraction technique could theoretically achieve satisfactory reduction and fusion. However, its superiority has not been proven. Therefore, we design a RCT study to compare the reduction rate and fusion rate of different strategies.
- Conditions
- Atlantoaxial Dislocation
- Being tested
- Intra-articular Cages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular CagesDevice
Using reduction using posterior intra-articular distraction and fusion technique with cages.
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular Group | Experimental | Posterior intra-articular distraction and fusion Receives: Device: Intra-articular Cages |
| Posterior Group | No intervention | Posterior direct distraction and fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Rates
Atlantoaixal fusion rates
Measured: 12 months
Secondary outcomes (3)
Japanese Orthopaedic Association Scores
0-17 Scores
Measured: 12 months
Visual Analogue Scale
0-10 Scores
Measured: 12 months
Neck Disability Index
0-5 Scores
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start29 Jul 2024
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atlantoaxial DislocationStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003491
- Sponsor's protocol ID
- XW-NS-RCTRAAD
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen Z, Duan W, Chou D, Guan J, Liu Z, Jian Q, Zhang B, Bo X, Jian F. A Safe and Effective Posterior Intra-Articular Distraction Technique to Treat Congenital Atlantoaxial Dislocation Associated With Basilar Invagination: Case Series and Technical Nuances. Oper Neurosurg. 2021 Mar 15;20(4):334-342. doi: 10.1093/ons/opaa391.
PubMed 33372978
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation
- ClinicalTrials.gov ID
- NCT06003491
- Acronym / sponsor ID
- XW-NS-RCTRAAD
- Conditions
- Atlantoaxial Dislocation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 22 Aug 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.
The management of reducible atlantoaxial dislocation associated is challenging. Direct posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. In 2020, we modified this technique and proposed a posterior intra-articular distraction technique. The intra-articular distraction technique could theoretically achieve satisfactory reduction and fusion. However, its superiority has not been proven. Therefore, we design a RCT study to compare the reduction rate and fusion rate of different strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular Group | Experimental | Device: Intra-articular CagesPosterior intra-articular distraction and fusion |
| Posterior Group | No intervention | –Posterior direct distraction and fusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CT indicated atlantoaxial dislocation Agree with the operation plan Agree to be followed up
Key exclusion criteria (1 listed)
- The pathology is traumatic or RA Underwent operations in occipital-cervical region before With mortal diseases Without ability to sign papers
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 |
|---|---|---|
| Intra-articular CagesUsing reduction using posterior intra-articular distraction and fusion technique with cages. | Device | Intra-articular Group |
Primary outcome
Fusion Rates
Time frame: 12 months
Atlantoaixal fusion rates
3 secondary outcomes
Japanese Orthopaedic Association Scores
Time frame: 12 months
Visual Analogue Scale
Time frame: 12 months
Neck Disability Index
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 33372978Chen Z, Duan W, Chou D, Guan J, Liu Z, Jian Q, Zhang B, Bo X, Jian F. A Safe and Effective Posterior Intra-Articular Distraction Technique to Treat Congenital Atlantoaxial Dislocation Associated With Basilar Invagination: Case Series and Technical Nuances. Oper Neurosurg. 2021 Mar 15;20(4):334-342. doi: 10.1093/ons/opaa391.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular Cages in people with Atlantoaxial Dislocation, run by Xuanwu Hospital, Beijing at 1 site in China.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zan Chen, MD (+8613911712120, chenzan66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion Rates (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06003491, which also lists 1 linked publication.
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 21 Oct 2026.