Basilar Invagination, Prospective Study, Surgical Outcome
Conditions
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.
Interventions
PROCEDUREPosterior fossa decompression
Posterior fossa decompression：Posterior arch of atlas removal, decompression of cerebellum, detection of foramen magnum.
PROCEDUREPosterior 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.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NDI Score | 1 months, 3 months, and 6 months postoperatively | Changes in NDI score，from 0% to 100%，higher scores means worse outcome |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactZan Chen
Backup ContactBoyan Zhang
Outcome results
None listed