UnknownNot Applicable

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

China200 participantsStarted 2022-02-06

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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.

What they're measuring

improved symptoms

Timeframe: 1 months postoperatively

improved symptoms

Timeframe: 3 months postoperatively

improved symptoms

Timeframe: 6 months postoperatively

improved radiology

Timeframe: 1 months postoperatively

improved radiology

Timeframe: 3 months postoperatively

improved radiology

Timeframe: 6 months postoperatively

operation complication

Timeframe: 1 months postoperatively

operation complication

Timeframe: 3 months postoperatively

operation complication

Timeframe: 6 months postoperatively

Trial details

NCT IDNCT05909540

SponsorXuanwu Hospital, Beijing

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-01

View on ClinicalTrials.gov More Basilar Invagination trials

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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.

What they're measuring

improved symptoms

Timeframe: 1 months postoperatively

improved symptoms

Timeframe: 3 months postoperatively

improved symptoms

Timeframe: 6 months postoperatively

improved radiology

Timeframe: 1 months postoperatively

improved radiology

Timeframe: 3 months postoperatively

improved radiology

Timeframe: 6 months postoperatively

operation complication

Timeframe: 1 months postoperatively

operation complication

Timeframe: 3 months postoperatively

operation complication

Timeframe: 6 months postoperatively