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

NCT05849363 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-07-19

No results posted yet for this study

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. 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

Interventions

PROCEDURE

Posterior fossa decompression

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

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.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-06-01
Completion
2025-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05849363 on ClinicalTrials.gov