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

Not Applicable

Recruiting

• Conditions: Prospective Study; Basilar Invagination; Surgical Outcome
• Interventions: Procedure: Posterior fossa decompression; Procedure: Posterior Compression-Distraction-Reduction-Fixation

• Registration Number: NCT05849363
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-09
• Status Verified: 2023-03
• Study First Submitted QC: 2023-05-06
• Study First Posted: 2023-05-08
• Study Start: 2023-06-01
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-19
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Posterior fossa decompression	Posterior fossa decompression	Posterior arch of atlas removal, reconstruction of cisterna magna, decompression of cerebellum, detection of magendie foramen.
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.

Primary Outcome Measures

Name	Time	Method
JOA Score（Japanese Orthopaedic Association Scores）	1 months, 3 months, and 6 months postoperatively	Changes in JOA score，from 0 to 17, higher scores means better outcome
NDI Score	1 months, 3 months, and 6 months postoperatively	Changes in NDI score，from 0% to 100%，higher scores means worse outcome

Secondary Outcome Measures

Name	Time	Method
Change of Basilar Invagination	1 months, 3 months, and 6 months postoperatively	Radiographic assessment of the reduction of basilar invagination, using distance from odontoid tip to Chamberlain's line (DCL)
Change of CVJ triangle area	1 months, 3 months, and 6 months postoperatively	Radiographic assessment of the reduction of CVJ triangle area
Change of subarachnoid space	1 months, 3 months, and 6 months postoperatively	Radiographic assessment of the relief of width of subarachnoid space
Change of CCA	1 months, 3 months, and 6 months postoperatively	Radiographic assessment of the change in clivus-canal angle (CCA)
Change of CMA	1 months, 3 months, and 6 months postoperatively	Radiographic assessment of change of cervico-medullary angle (CMA)

Trial Locations

Locations (1)

Xuanwu Hospital; 🇨🇳 Beijing, Beijing, China