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

Prospective Study Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849363
• Other study ID #: XW-NS-GBTBI
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: March 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Zan Chen
• Phone: +8613911712120
• Email: chenzan66[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Basilar Invagination
• Intussusception
• Prospective Study
• Surgical Outcome

Intervention

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

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	JOA Score(Japanese Orthopaedic Association Scores)	Changes in JOA score,from 0 to 17, higher scores means better outcome	1 months, 3 months, and 6 months postoperatively
Primary	NDI Score	Changes in NDI score,from 0% to 100%,higher scores means worse outcome	1 months, 3 months, and 6 months postoperatively
Secondary	Change of Basilar Invagination	Radiographic assessment of the reduction of basilar invagination, using distance from odontoid tip to Chamberlain's line (DCL)	1 months, 3 months, and 6 months postoperatively
Secondary	Change of CCA	Radiographic assessment of the change in clivus-canal angle (CCA)	1 months, 3 months, and 6 months postoperatively
Secondary	Change of CVJ triangle area	Radiographic assessment of the reduction of CVJ triangle area	1 months, 3 months, and 6 months postoperatively
Secondary	Change of CMA	Radiographic assessment of change of cervico-medullary angle (CMA)	1 months, 3 months, and 6 months postoperatively
Secondary	Change of subarachnoid space	Radiographic assessment of the relief of width of subarachnoid space	1 months, 3 months, and 6 months postoperatively