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

• Conditions: Basilar Invagination
• Interventions: Procedure: Posterior facet distraction and fusion

• Registration Number: NCT05909540
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-02-06
• Status Verified: 2023-04
• Study First Submitted: 2023-04-02
• Study First Submitted QC: 2023-06-11
• Last Update Submitted: 2023-06-11
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18
• Primary Completion: 2023-12-01
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Goel A Type Basilar Invagination	Posterior facet distraction and fusion	1) ADI\>3mm in adults, or ADI\>5mm in child.
Goel B Type Basilar Invagination	Posterior facet distraction and fusion	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.

Primary Outcome Measures

Name	Time	Method
operation complication	6 months postoperatively	operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）
improved symptoms	6 months postoperatively	The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）
improved radiology	6 months postoperatively	improved ADI, CCA, CTA ; The basilar invagination reduced

Trial Locations

Locations (1)

Xuanwu Hospital， Capital Medical University; 🇨🇳 Beijing, China