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

Sponsor

Xuanwu Hospital, Beijing (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05849363

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Basilar Invagination Prospective Study Surgical Outcome	Procedure: Posterior fossa decompression Procedure: Posterior Compression-Distraction-Reduction-Fixation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Posterior fossa decompression Posterior arch of atlas removal, reconstruction of cisterna magna, decompression of cerebellum, detection of magendie foramen.	Procedure: Posterior fossa decompression Posterior fossa decompression：Posterior arch of atlas removal, decompression of cerebellum, detection of foramen magnum.
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: Posterior fossa decompression

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

Procedure: Posterior fossa decompression

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

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

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

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 CCA [1 months, 3 months, and 6 months postoperatively]
Radiographic assessment of the change in clivus-canal angle (CCA)
Change of CVJ triangle area [1 months, 3 months, and 6 months postoperatively]
Radiographic assessment of the reduction of CVJ triangle area
Change of CMA [1 months, 3 months, and 6 months postoperatively]
Radiographic assessment of change of cervico-medullary angle (CMA)
Change of subarachnoid space [1 months, 3 months, and 6 months postoperatively]
Radiographic assessment of the relief of width of subarachnoid space

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xuanwu Hospital	Beijing	Beijing	China	100000

Sponsors and Collaborators

Xuanwu Hospital, Beijing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xuanwu Hospital, Beijing

ClinicalTrials.gov Identifier:

NCT05849363

Other Study ID Numbers:

XW-NS-GBTBI

First Posted:

May 8, 2023

Last Update Posted:

May 8, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Platybasia

Intussusception

Study Results

No Results Posted as of May 8, 2023