NCT05909540

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 6, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

June 18, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

April 2, 2023

Last Update Submit

June 11, 2023

Conditions

Basilar Invagination

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (2)

Goel A Type Basilar Invagination

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

Procedure: Posterior facet distraction and fusion

Goel B Type Basilar Invagination

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.

Procedure: Posterior facet distraction and fusion

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.

Goel A Type Basilar InvaginationGoel B Type Basilar Invagination

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with primary basilar depression

You may qualify if:

  • BI discovered by the patient not incidentally;
  • Patients with depression of the skull base caused by congenital skeletal developmental malformations and symptoms;
  • The patient was initially treated in our center, and the interval between onset and treatment was at least 1 month or no treatment;
  • The imaging diagnosis of BI meets the standard (3-5mm higher than the Chamberlain's line)

You may not qualify if:

  • 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.
  • spinal vascular disease, intervertebral disc herniation, tethered spinal cord disease and other diseases that may cause symptoms.
  • Patients with incomplete imaging data or symptomatic data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital， Capital Medical University

Beijing, 100053, China

Location

MeSH Terms

Interventions

Gene Fusion

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic Phenomena

Study Officials

  • Zan Chen, MD. PHD.

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2023

First Posted

June 18, 2023

Study Start

February 6, 2022

Primary Completion

December 1, 2023

Study Completion

June 30, 2024

Last Updated

June 18, 2023

Record last verified: 2023-04

Locations

CN(1)