A Prospective Study of Surgical Treatment Strategies for Goal B Type Basilar Invagination

NCT ID: NCT05849363

Last Updated: 2023-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Basilar Invagination Prospective Study Surgical Outcome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Posterior fossa decompression

Posterior arch of atlas removal, reconstruction of cisterna magna, decompression of cerebellum, detection of magendie foramen.

Group Type EXPERIMENTAL

Posterior fossa decompression

Intervention Type PROCEDURE

Posterior fossa decompression:Posterior arch of atlas removal, decompression of cerebellum, detection of foramen magnum.

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.

Group Type EXPERIMENTAL

Posterior Compression-Distraction-Reduction-Fixation

Intervention Type PROCEDURE

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.

Interventions

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Posterior fossa decompression

Posterior fossa decompression:Posterior arch of atlas removal, decompression of cerebellum, detection of foramen magnum.

Intervention Type PROCEDURE

Posterior Compression-Distraction-Reduction-Fixation

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Goal B type basilar invagination (BI)

Exclusion Criteria

* Preoperative diagnosis was confirmed as not Goal B type basilar invagination (BI)
* The patient was not physically fit for surgery.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xuanwu Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zan Chen

Role: CONTACT

+8613911712120

Boyan Zhang

Role: CONTACT

+8618611632250

Facility Contacts

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Zan Chen

Role: primary

+861083198899

Other Identifiers

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XW-NS-GBTBI

Identifier Type: -

Identifier Source: org_study_id

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