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

Not Applicable

Recruiting

• Conditions: Prospective Study; Basilar Invagination; Surgical Outcome

• 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

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