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

Capital Medical University

Status: Invitation-only

Conditions: Basilar Invagination

Treatments: Procedure: Posterior facet distraction and fusion

Study type: Observational

Funder types: Other

Identifiers

NCT05909540

XW-NS-PNHBI

Details and patient eligibility

About

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

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Goel A Type Basilar Invagination

Description:

1) ADI\>3mm in adults, or ADI\>5mm in child.

Treatment:

Procedure: Posterior facet distraction and fusion

Goel B Type Basilar Invagination

Description:

1. ADI\<3mm in adults, or ADI\<5mm in child. 2. The stabilization in atlantoaxial could can be found. 3. The tip of odontoid can exceed the Chamberlian's line， but not exceed the Wackenheim's line and Mcrae's line.

Treatment:

Procedure: Posterior facet distraction and fusion