Atlantoaxial DislocationNCT05978375
A Prospective Cohort Study of for Surgical Treatment of Irreducible Atlantoaxial Dislocation
An observational study of Atlantoaxial Dislocation, run by Xuanwu Hospital, Beijing.
Trial summary
The management of irreducible 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?
- Posterior intra-articular distraction and fusion, Anterior transoral release and posterior cantilever reduction and fusion and TARP
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Sep 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 18-70, exclude traumatic, RA and previous surgery.
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
No sites are listed yet.
About this study
The management of irreducible 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 prospective study to compare the reduction rate and fusion rate of different strategies.
- Conditions
- Atlantoaxial Dislocation
- Being tested
- Posterior intra-articular distraction and fusion, Anterior transoral release and posterior cantilever reduction and fusion, TARP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior intra-articular distraction and fusionProcedure or surgery
Using reduction using posterior intra-articular distraction and fusion technique.
Anterior transoral release and posterior cantilever reduction and fusionProcedure or surgery
Using anterior transoral release and posterior cantilever reduction and fusion technique.
TARPProcedure or surgery
Using TARP technique.
| Study group | Role | What they receive |
|---|---|---|
| Irreducible Atlantoaxial Dislocation | Atlantoaxial dislocation which could not be reducted under anesthesia traction with 1/6 weight. Receives: Procedure: Posterior intra-articular distraction and fusion; Procedure: Anterior transoral release and posterior cantilever reduction and fusion; Procedure: TARP |
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 posted7 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 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
- NCT05978375
- Sponsor's protocol ID
- XW-NS-PROIAAD
- Status last verified
- Jul 2023
- First submitted
- 30 Jul 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of for Surgical Treatment of Irreducible Atlantoaxial Dislocation
- ClinicalTrials.gov ID
- NCT05978375
- Acronym / sponsor ID
- XW-NS-PROIAAD
- Conditions
- Atlantoaxial Dislocation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 7 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 irreducible 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 prospective study to compare the reduction rate and fusion rate of different strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irreducible Atlantoaxial Dislocation | – | Procedure: Posterior intra-articular distraction and fusion, Procedure: Anterior transoral release and posterior cantilever reduction and fusion, Procedure: TARPAtlantoaxial dislocation which could not be reducted under anesthesia traction with 1/6 weight. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-70, exclude traumatic, RA and previous surgery.
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 |
|---|---|---|
| Posterior intra-articular distraction and fusionUsing reduction using posterior intra-articular distraction and fusion technique. | Procedure or surgery | Irreducible Atlantoaxial Dislocation |
| Anterior transoral release and posterior cantilever reduction and fusionUsing anterior transoral release and posterior cantilever reduction and fusion technique. | Procedure or surgery | Irreducible Atlantoaxial Dislocation |
| TARPUsing TARP technique. | Procedure or surgery | Irreducible Atlantoaxial Dislocation |
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- 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.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atlantoaxial Dislocation, run by Xuanwu Hospital, Beijing.
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: status not confirmed, as of the sponsor's last update on 23 Aug 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?
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 NCT05978375, 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 23 Aug 2023.