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

Primary Purpose

Basilar Invagination, Prospective Study, Surgical Outcome

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Posterior fossa decompression

Posterior Compression-Distraction-Reduction-Fixation

About this trial

This is an interventional treatment trial for Basilar Invagination

Eligibility Criteria

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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.

Sites / Locations

Xuanwu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Posterior fossa decompression

Posterior Compression-Distraction-Reduction-Fixation

Arm Description

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

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.

Outcomes

Primary Outcome Measures

JOA Score（Japanese Orthopaedic Association Scores）

Changes in JOA score，from 0 to 17, higher scores means better outcome

NDI Score

Changes in NDI score，from 0% to 100%，higher scores means worse outcome

Secondary Outcome Measures

Change of Basilar Invagination

Radiographic assessment of the reduction of basilar invagination, using distance from odontoid tip to Chamberlain's line (DCL)

Change of CCA

Radiographic assessment of the change in clivus-canal angle (CCA)

Change of CVJ triangle area

Radiographic assessment of the reduction of CVJ triangle area

Change of CMA

Radiographic assessment of change of cervico-medullary angle (CMA)

Change of subarachnoid space

Radiographic assessment of the relief of width of subarachnoid space

Full Information

NCT ID

NCT05849363

First Posted

October 9, 2022

Last Updated

July 17, 2023

Sponsor

Xuanwu Hospital, Beijing

1. Study Identification

Unique Protocol Identification Number

NCT05849363

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2023 (Actual)

Primary Completion Date

June 1, 2025 (Anticipated)

Study Completion Date

September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xuanwu Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Basilar Invagination, Prospective Study, Surgical Outcome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Posterior fossa decompression

Arm Type

Experimental

Arm Description

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

Arm Title

Posterior Compression-Distraction-Reduction-Fixation

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Posterior fossa decompression

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Posterior Compression-Distraction-Reduction-Fixation

Intervention Description

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 Measure Information:

Title

JOA Score（Japanese Orthopaedic Association Scores）

Description

Changes in JOA score，from 0 to 17, higher scores means better outcome

Time Frame

1 months, 3 months, and 6 months postoperatively

Title

NDI Score

Description

Changes in NDI score，from 0% to 100%，higher scores means worse outcome

Time Frame

1 months, 3 months, and 6 months postoperatively

Secondary Outcome Measure Information:

Title

Change of Basilar Invagination

Description

Radiographic assessment of the reduction of basilar invagination, using distance from odontoid tip to Chamberlain's line (DCL)

Time Frame

1 months, 3 months, and 6 months postoperatively

Title

Change of CCA

Description

Radiographic assessment of the change in clivus-canal angle (CCA)

Time Frame

1 months, 3 months, and 6 months postoperatively

Title

Change of CVJ triangle area

Description

Radiographic assessment of the reduction of CVJ triangle area

Time Frame

1 months, 3 months, and 6 months postoperatively

Title

Change of CMA

Description

Radiographic assessment of change of cervico-medullary angle (CMA)

Time Frame

1 months, 3 months, and 6 months postoperatively

Title

Change of subarachnoid space

Description

Radiographic assessment of the relief of width of subarachnoid space

Time Frame

1 months, 3 months, and 6 months postoperatively

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zan Chen

Phone

+8613911712120

chenzan66@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Boyan Zhang

Phone

+8618611632250

zhangboyan1997@foxmail.com

Facility Information:

Facility Name

Xuanwu Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zan Chen

Phone

+861083198899

chenzan66@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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