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

NCT05849363 | Unknown

• 1 other identifier: XW-NS-GBTBI
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Basilar Invagination; Prospective Study; Surgical Outcome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change of Basilar Invagination

  1 months, 3 months, and 6 months postoperatively

• Change of CCA

  1 months, 3 months, and 6 months postoperatively

• Change of CVJ triangle area

  1 months, 3 months, and 6 months postoperatively

• Change of CMA

  1 months, 3 months, and 6 months postoperatively

• Change of subarachnoid space

  1 months, 3 months, and 6 months postoperatively

Study Arms (2)

Posterior fossa decompression

EXPERIMENTAL

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

Procedure: Posterior fossa decompression

Posterior Compression-Distraction-Reduction-Fixation

EXPERIMENTAL

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

Interventions

Posterior fossa decompression PROCEDURE

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

Posterior fossa decompression

Posterior Compression-Distraction-Reduction-Fixation PROCEDURE

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.

Posterior Compression-Distraction-Reduction-Fixation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Goal B type basilar invagination (BI)

You may not qualify if:

• Preoperative diagnosis was confirmed as not Goal B type basilar invagination (BI)
• The patient was not physically fit for surgery.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Central Study Contacts

Zan Chen

CONTACT

+8613911712120; chenzan66@163.com

Boyan Zhang

CONTACT

+8618611632250; zhangboyan1997@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: May 8, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 19, 2023

Record last verified: 2023-03

Locations

CN (1)