Basilar InvaginationNCT05909540
A Prospective Study of Natural History and Clinical Outcomes for Basilar Invagination
An observational study of Basilar Invagination, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
A Prospective Study of Natural History and Clinical Outcomes for Basilar Invagination Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Basilar Invagination
- What is being tested?
- Posterior facet distraction and fusion
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2022to 30 Jun 2024
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: patients with primary basilar depression
Who may be able to join
- BI discovered by the patient not incidentally;
- Patients with depression of the skull base caused by congenital skeletal developmental malformations and symptoms;
- The patient was initially treated in our center, and the interval between onset and treatment was at least 1 month or no treatment;
- The imaging diagnosis of BI meets the standard (3-5mm higher than the Chamberlain's line)
Who cannot join
- secondary BI caused by trauma, pathological factors such as rheumatoid arthritis, hyperparathyroidism, osteogenesis imperfecta, rickets, osteomalacia, spinal cord tumors, tuberculosis, inflammation of adjacent structures, and simple AAD, odontoid body deformity, etc.
- spinal vascular disease, intervertebral disc herniation, tethered spinal cord disease and other diseases that may cause symptoms.
- Patients with incomplete imaging data or symptomatic data.
Trial locations and contacts
1 site in 1 country.
About this study
A Prospective Study of Natural History and Clinical Outcomes for Basilar Invagination
Read the detailed description
Since basilar invagination was reported, its pathogenesis has been considered both primary and secondary. Surgical treatment methods emerged in an endless stream, and a hundred schools of thought contend. However, the link between the symptoms and imaging has not been studied in detail. We prospectively enrolled patients with basilar depression, and then explored the natural history of the disease and the clinical outcomes of early intervention.
- Conditions
- Basilar Invagination
- Being tested
- Posterior facet distraction and fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior facet distraction and fusionProcedure or surgery
With the patient in prone position, cervical traction was only intraoperatively after anesthesia with weights of approximately 5-8 kg during surgery. Monitoring of the spinal cord with motor evoked potential and somatosensory evoked potential were used throughout the surgery. Using a posterior midline incision, the occiput to the C2 spinous process was surgically exposed, separated to the lateral edge of the C1-2 joint, and cut off at the C2 nerve root to expose the C1-2 articular surface Quantitative reduction techniques included the following steps .1) Facet joint release and cage implantation technique 2)Adjusting POCA by cantilever and occipitocervical fixation technique.
| Study group | Role | What they receive |
|---|---|---|
| Goel A Type Basilar Invagination | 1) ADI>3mm in adults, or ADI>5mm in child. Receives: Procedure: Posterior facet distraction and fusion | |
| Goel B Type Basilar Invagination | 1. ADI<3mm in adults, or ADI<5mm in child.
2. The stabilization in atlantoaxial could can be found.
3. The tip of odontoid can exceed the Chamberlian's line， but not exceed the Wackenheim's line and Mcrae's line. Receives: Procedure: Posterior facet distraction and fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
improved symptoms
The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）
Measured: 1 months postoperatively
improved symptoms
The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）
Measured: 3 months postoperatively
improved symptoms
The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）
Measured: 6 months postoperatively
improved radiology
improved ADI, CCA, CTA ; The basilar invagination reduced
Measured: 1 months postoperatively
improved radiology
improved ADI, CCA, CTA ; The basilar invagination reduced
Measured: 3 months postoperatively
improved radiology
improved ADI, CCA, CTA ; The basilar invagination reduced
Measured: 6 months postoperatively
operation complication
operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）
Measured: 1 months postoperatively
operation complication
operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）
Measured: 3 months postoperatively
operation complication
operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start6 Feb 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basilar InvaginationStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zan Chen, MD. PHD., Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909540
- Sponsor's protocol ID
- XW-NS-PNHBI
- Status last verified
- Apr 2023
- First submitted
- 2 Apr 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Natural History and Clinical Outcomes for Basilar Invagination
- ClinicalTrials.gov ID
- NCT05909540
- Acronym / sponsor ID
- XW-NS-PNHBI
- Conditions
- Basilar Invagination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 6 Feb 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 18 Jun 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.
A Prospective Study of Natural History and Clinical Outcomes for Basilar Invagination
Detailed description
Since basilar invagination was reported, its pathogenesis has been considered both primary and secondary. Surgical treatment methods emerged in an endless stream, and a hundred schools of thought contend. However, the link between the symptoms and imaging has not been studied in detail. We prospectively enrolled patients with basilar depression, and then explored the natural history of the disease and the clinical outcomes of early intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goel A Type Basilar Invagination | – | Procedure: Posterior facet distraction and fusion1) ADI>3mm in adults, or ADI>5mm in child. |
| Goel B Type Basilar Invagination | – | Procedure: Posterior facet distraction and fusion1. ADI<3mm in adults, or ADI<5mm in child. 2. The stabilization in atlantoaxial could can be found. 3. The tip of odontoid can exceed the Chamberlian's line， but not exceed the Wackenheim's line and Mcrae's line. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with primary basilar depression
Key inclusion criteria (4 listed)
- BI discovered by the patient not incidentally;
- Patients with depression of the skull base caused by congenital skeletal developmental malformations and symptoms;
- The patient was initially treated in our center, and the interval between onset and treatment was at least 1 month or no treatment;
- The imaging diagnosis of BI meets the standard (3-5mm higher than the Chamberlain's line)
Key exclusion criteria (3 listed)
- secondary BI caused by trauma, pathological factors such as rheumatoid arthritis, hyperparathyroidism, osteogenesis imperfecta, rickets, osteomalacia, spinal cord tumors, tuberculosis, inflammation of adjacent structures, and simple AAD, odontoid body deformity, etc.
- spinal vascular disease, intervertebral disc herniation, tethered spinal cord disease and other diseases that may cause symptoms.
- Patients with incomplete imaging data or symptomatic data.
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 facet distraction and fusionWith the patient in prone position, cervical traction was only intraoperatively after anesthesia with weights of approximately 5-8 kg during surgery. Monitoring of the spinal cord with motor evoked potential and somatosensory evoked potential were used throughout the surgery. Using a posterior midline incision, the occiput to the C2 spinous process was surgically exposed, separated to the lateral edge of the C1-2 joint, and cut off at the C2 nerve root to expose the C1-2 articular surface Quantitative reduction techniques included the following steps .1) Facet joint release and cage implantation technique 2)Adjusting POCA by cantilever and occipitocervical fixation technique. | Procedure or surgery | Goel A Type Basilar Invagination, Goel B Type Basilar Invagination |
Primary outcome
improved symptoms
Time frame: 1 months postoperatively
The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）
improved symptoms
Time frame: 3 months postoperatively
The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）
improved symptoms
Time frame: 6 months postoperatively
The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）
improved radiology
Time frame: 1 months postoperatively
improved ADI, CCA, CTA ; The basilar invagination reduced
improved radiology
Time frame: 3 months postoperatively
improved ADI, CCA, CTA ; The basilar invagination reduced
improved radiology
Time frame: 6 months postoperatively
improved ADI, CCA, CTA ; The basilar invagination reduced
operation complication
Time frame: 1 months postoperatively
operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）
operation complication
Time frame: 3 months postoperatively
operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）
operation complication
Time frame: 6 months postoperatively
operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Undecided
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.
Zan Chen, MD. PHD. principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basilar Invagination, 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 4 inclusion and 3 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 18 Jun 2023. 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?
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?
improved symptoms (time frame: 1 months postoperatively). The study lists 9 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 18 Jun 2023.