Basilar InvaginationNCT05849363
A Prospective Study of Surgical Treatment Strategies for Goal B Type Basilar Invagination
A study testing Posterior fossa decompression and Posterior Compression-Distraction-Reduction-Fixation in people with Basilar Invagination and Prospective Study, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The etiology of Goal B type basilar invagination (BI) is still not clear, and it may be related to platybasia and short slope. There is no unified standard surgical strategy for Goal B type BI, and different surgical strategies have a great influence on the surgical results of patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Basilar Invagination, Prospective Study, Surgical Outcome
- What is being tested?
- Posterior fossa decompression and Posterior Compression-Distraction-Reduction-Fixation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Sep 2025
- Phase
- Interventional
- 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
Who may be able to join
- Goal B type basilar invagination (BI)
Who cannot join
- Preoperative diagnosis was confirmed as not Goal B type basilar invagination (BI)
- The patient was not physically fit for surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, Beijing Municipality, 100000
Zan Chen, +861083198899, chenzan66@163.com
About this study
Official title: A Prospective Study of Surgical Treatment Strategies for Goal B Type Basilar Invagination in China
The etiology of Goal B type basilar invagination (BI) is still not clear, and it may be related to platybasia and short slope. There is no unified standard surgical strategy for Goal B type BI, and different surgical strategies have a great influence on the surgical results of patients. The purpose of our prospective study in China is to (1) further clarify the etiology of Goal B type BI, and (2) improve the surgical outcome in these patients.
- Conditions
- Basilar Invagination, Prospective Study, Surgical Outcome
- Being tested
- Posterior fossa decompression, Posterior Compression-Distraction-Reduction-Fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior fossa decompressionProcedure or surgery
Posterior fossa decompression：Posterior arch of atlas removal, decompression of cerebellum, detection of foramen magnum.
Posterior Compression-Distraction-Reduction-FixationProcedure or surgery
Posterior Compression-Distraction-Reduction-Fixation：After subperiosteal dissection, the facet joint was exposed. A 2-mm joint "scraper" with sharp edge was inserted into the joint capsule and rotated to remove the articular cartilage. A blunt-edged rotating distractor was then inserted into the joint space, and the facet was sequentially opened with larger and larger blunt rotating distractors. After distraction on one side, an appropriate-sized trial was placed into the contralateral facet, holding the distraction open. This was repeated back and forth with larger trials. These steps were repeated, and the facet joints were distracted up to the pre-planned distance of the odontoid tip above Chamberlain's line.
| Study group | Role | What they receive |
|---|---|---|
| Posterior fossa decompression | Experimental | Posterior arch of atlas removal, reconstruction of cisterna magna, decompression of cerebellum, detection of magendie foramen. Receives: Procedure: Posterior fossa decompression |
| Posterior Compression-Distraction-Reduction-Fixation | Experimental | After subperiosteal dissection, the facet joint was exposed. A 2-mm joint "scraper" with sharp edge was inserted into the joint capsule and rotated to remove the articular cartilage. A blunt-edged rotating distractor was then inserted into the joint space, and the facet was sequentially opened with larger and larger blunt rotating distractors. After distraction on one side, an appropriate-sized trial was placed into the contralateral facet, holding the distraction open. This was repeated back and forth with larger trials. These steps were repeated, and the facet joints were distracted up to the pre-planned distance of the odontoid tip above Chamberlain's line. Receives: Procedure: Posterior Compression-Distraction-Reduction-Fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
JOA Score（Japanese Orthopaedic Association Scores）
Changes in JOA score，from 0 to 17, higher scores means better outcome
Measured: 1 months, 3 months, and 6 months postoperatively
NDI Score
Changes in NDI score，from 0% to 100%，higher scores means worse outcome
Measured: 1 months, 3 months, and 6 months postoperatively
Secondary outcomes (5)
Change of Basilar Invagination
Radiographic assessment of the reduction of basilar invagination, using distance from odontoid tip to Chamberlain's line (DCL)
Measured: 1 months, 3 months, and 6 months postoperatively
Change of CCA
Radiographic assessment of the change in clivus-canal angle (CCA)
Measured: 1 months, 3 months, and 6 months postoperatively
Change of CVJ triangle area
Radiographic assessment of the reduction of CVJ triangle area
Measured: 1 months, 3 months, and 6 months postoperatively
Change of CMA
Radiographic assessment of change of cervico-medullary angle (CMA)
Measured: 1 months, 3 months, and 6 months postoperatively
Change of subarachnoid space
Radiographic assessment of the relief of width of subarachnoid space
Measured: 1 months, 3 months, and 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 posted8 May 2023
- Study start1 Jun 2023
- Primary completion1 Jun 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 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
- NCT05849363
- Sponsor's protocol ID
- XW-NS-GBTBI
- Status last verified
- Mar 2023
- First submitted
- 9 Oct 2022
- Last updated
- 19 Jul 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 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Surgical Treatment Strategies for Goal B Type Basilar Invagination in China
- ClinicalTrials.gov ID
- NCT05849363
- Acronym / sponsor ID
- XW-NS-GBTBI
- Conditions
- Basilar Invagination, Prospective Study, Surgical Outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 8 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.
The etiology of Goal B type basilar invagination (BI) is still not clear, and it may be related to platybasia and short slope. There is no unified standard surgical strategy for Goal B type BI, and different surgical strategies have a great influence on the surgical results of patients. The purpose of our prospective study in China is to (1) further clarify the etiology of Goal B type BI, and (2) improve the surgical outcome in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior fossa decompression | Experimental | Procedure: Posterior fossa decompressionPosterior arch of atlas removal, reconstruction of cisterna magna, decompression of cerebellum, detection of magendie foramen. |
| Posterior Compression-Distraction-Reduction-Fixation | Experimental | Procedure: Posterior Compression-Distraction-Reduction-FixationAfter subperiosteal dissection, the facet joint was exposed. A 2-mm joint "scraper" with sharp edge was inserted into the joint capsule and rotated to remove the articular cartilage. A blunt-edged rotating distractor was then inserted into the joint space, and the facet was sequentially opened with larger and larger blunt rotating distractors. After distraction on one side, an appropriate-sized trial was placed into the contralateral facet, holding the distraction open. This was repeated back and forth with larger trials. These steps were repeated, and the facet joints were distracted up to the pre-planned distance of the odontoid tip above Chamberlain's line. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Goal B type basilar invagination (BI)
Key exclusion criteria (2 listed)
- Preoperative diagnosis was confirmed as not Goal B type basilar invagination (BI)
- The patient was not physically fit for surgery.
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 fossa decompressionPosterior fossa decompression：Posterior arch of atlas removal, decompression of cerebellum, detection of foramen magnum. | Procedure or surgery | Posterior fossa decompression |
| Posterior Compression-Distraction-Reduction-FixationPosterior Compression-Distraction-Reduction-Fixation：After subperiosteal dissection, the facet joint was exposed. A 2-mm joint "scraper" with sharp edge was inserted into the joint capsule and rotated to remove the articular cartilage. A blunt-edged rotating distractor was then inserted into the joint space, and the facet was sequentially opened with larger and larger blunt rotating distractors. After distraction on one side, an appropriate-sized trial was placed into the contralateral facet, holding the distraction open. This was repeated back and forth with larger trials. These steps were repeated, and the facet joints were distracted up to the pre-planned distance of the odontoid tip above Chamberlain's line. | Procedure or surgery | Posterior Compression-Distraction-Reduction-Fixation |
Primary outcome
JOA Score（Japanese Orthopaedic Association Scores）
Time frame: 1 months, 3 months, and 6 months postoperatively
Changes in JOA score，from 0 to 17, higher scores means better outcome
NDI Score
Time frame: 1 months, 3 months, and 6 months postoperatively
Changes in NDI score，from 0% to 100%，higher scores means worse outcome
5 secondary outcomes
Change of Basilar Invagination
Time frame: 1 months, 3 months, and 6 months postoperatively
Change of CCA
Time frame: 1 months, 3 months, and 6 months postoperatively
Change of CVJ triangle area
Time frame: 1 months, 3 months, and 6 months postoperatively
Change of CMA
Time frame: 1 months, 3 months, and 6 months postoperatively
Change of subarachnoid space
Time frame: 1 months, 3 months, and 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior fossa decompression and Posterior Compression-Distraction-Reduction-Fixation in people with Basilar Invagination and Prospective Study, 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 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 19 Jul 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?
Contact Zan Chen (+8613911712120, chenzan66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
JOA Score（Japanese Orthopaedic Association Scores） (time frame: 1 months, 3 months, and 6 months postoperatively). The study lists 2 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 19 Jul 2023.