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

Capital Medical University

Status: Enrolling

Conditions: Prospective Study; Basilar Invagination; Surgical Outcome

Treatments: Procedure: Posterior fossa decompression; Procedure: Posterior Compression-Distraction-Reduction-Fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT05849363

XW-NS-GBTBI

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Posterior fossa decompression

Experimental group

Description:

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

Treatment:

Procedure: Posterior fossa decompression

Posterior Compression-Distraction-Reduction-Fixation

Experimental group

Description:

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.

Treatment:

Procedure: Posterior Compression-Distraction-Reduction-Fixation