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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Basilar Invagination; Prospective Study; Surgical Outcome
• Intervention / Treatment: Procedure: Posterior fossa decompression; Procedure: Posterior Compression-Distraction-Reduction-Fixation

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zan Chen; Phone Number: +8613911712120; Email: chenzan66@163.com
• Study Contact Backup: Name: Boyan Zhang; Phone Number: +8618611632250; Email: zhangboyan1997@foxmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Xuanwu Hospital
      • Contact: Zan Chen; Phone Number: +861083198899; Email: chenzan66@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
NDI Score	Changes in NDI score，from 0% to 100%，higher scores means worse outcome	1 months, 3 months, and 6 months postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 9, 2022
• First Submitted That Met QC Criteria: May 6, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Musculoskeletal Diseases; Intestinal Diseases; Spinal Diseases; Bone Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Intestinal Obstruction; Intussusception; Platybasia
• Other Study ID Numbers: XW-NS-GBTBI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No