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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Basilar Invagination
• Intervention / Treatment: Procedure: Posterior facet distraction and fusion

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Xuanwu Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

patients with primary basilar depression

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Goel A Type Basilar Invagination; 1) ADI>3mm in adults, or ADI>5mm in child.	Procedure: Posterior facet distraction and fusion; 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.
Goel B Type Basilar Invagination; ADI<3mm in adults, or ADI<5mm in child.; The stabilization in atlantoaxial could can be found.; The tip of odontoid can exceed the Chamberlian's line， but not exceed the Wackenheim's line and Mcrae's line.	Procedure: Posterior facet distraction and fusion; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improved symptoms	The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）	1 months postoperatively
improved symptoms	The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）	3 months postoperatively
improved symptoms	The symptoms improved after the opration or natural condition.（JOA scores and SF-12 scores）	6 months postoperatively
improved radiology	improved ADI, CCA, CTA ; The basilar invagination reduced	1 months postoperatively
improved radiology	improved ADI, CCA, CTA ; The basilar invagination reduced	3 months postoperatively
improved radiology	improved ADI, CCA, CTA ; The basilar invagination reduced	6 months postoperatively
operation complication	operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）	1 months postoperatively
operation complication	operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）	3 months postoperatively
operation complication	operation complication（Excessive bleeding, bronchopneumonia, vertebral artery injury ）	6 months postoperatively

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Investigators: Principal Investigator: Zan Chen, MD. PHD., Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: April 2, 2023
• First Submitted That Met QC Criteria: June 11, 2023
• First Posted (Estimated): June 19, 2023

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Musculoskeletal Diseases; Intestinal Diseases; Spinal Diseases; Bone Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Intestinal Obstruction; Intussusception; Platybasia
• Other Study ID Numbers: XW-NS-PNHBI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No