A Prospective Study of Natural History and Clinical Outcomes for Basilar Invagination

Xuanwu Hospital, Beijing200 enrolled

Overview

Since basilar invagination was reported, its pathogenesis has been considered both primary and secondary. Surgical treatment methods emerged in an endless stream, and a hundred schools of thought contend. However, the link between the symptoms and imaging has not been studied in detail. We prospectively enrolled patients with basilar depression, and then explored the natural history of the disease and the clinical outcomes of early intervention.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Basilar Invagination

Interventions

Posterior facet distraction and fusionPROCEDURE

With the patient in prone position, cervical traction was only intraoperatively after anesthesia with weights of approximately 5-8 kg during surgery. Monitoring of the spinal cord with motor evoked potential and somatosensory evoked potential were used throughout the surgery. Using a posterior midline incision, the occiput to the C2 spinous process was surgically exposed, separated to the lateral edge of the C1-2 joint, and cut off at the C2 nerve root to expose the C1-2 articular surface Quantitative reduction techniques included the following steps .1) Facet joint release and cage implantation technique 2)Adjusting POCA by cantilever and occipitocervical fixation technique.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. BI discovered by the patient not incidentally; 2. Patients with depression of the skull base caused by congenital skeletal developmental malformations and symptoms; 3. The patient was initially treated in our center, and the interval between onset and treatment was at least 1 month or no treatment; 4. The imaging diagnosis of BI meets the standard (3-5mm higher than the Chamberlain's line) Exclusion Criteria: 1. secondary BI caused by trauma, pathological factors such as rheumatoid arthritis, hyperparathyroidism, osteogenesis imperfecta, rickets, osteomalacia, spinal cord tumors, tuberculosis, inflammation of adjacent structures, and simple AAD, odontoid body deformity, etc. 2. spinal vascular disease, intervertebral disc herniation, tethered spinal cord disease and other diseases that may cause symptoms. 3. Patients with incomplete imaging data or symptomatic data.

Locations (1)

Xuanwu Hospital， Capital Medical University

Beijing, China

Outcomes

Primary Outcomes

improved symptoms

The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）

Time frame: 1 months postoperatively

improved symptoms

The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）

Time frame: 3 months postoperatively

improved symptoms

The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）

Time frame: 6 months postoperatively

improved radiology

improved ADI, CCA, CTA ; The basilar invagination reduced

Time frame: 1 months postoperatively

improved radiology

improved ADI, CCA, CTA ; The basilar invagination reduced

Time frame: 3 months postoperatively

improved radiology

improved ADI, CCA, CTA ; The basilar invagination reduced

Time frame: 6 months postoperatively

operation complication

operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）

Time frame: 1 months postoperatively

operation complication

operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）

Time frame: 3 months postoperatively

operation complication

Data from ClinicalTrials.gov

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