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

Basilar Invagination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05909540
• Other study ID #: XW-NS-PNHBI
• Status: Enrolling by invitation
• Start date: February 6, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2023
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Basilar Invagination
• Intussusception

Intervention

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.

Locations

Country	Name	City	State
China	Xuanwu Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

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