Is instrumented fixation of the cranio-vertebral junction a better treatment for Chiari Malformation with or without syrnix
- Conditions
- Health Condition 1: G988- Other disorders of nervous system
- Registration Number
- CTRI/2019/04/018751
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusive criteria: Chiari 1 malformations with the following
1.At least 5 mm cerebellar herniation caudal to foramen magnum.
2.And/or if less than 5 mm but associated with â??peg shapedâ?? tonsils clearly showing evidence of obstruction of CSF pathways at the level of foramen magnum.
3.With or without presence of syringomyelia
4.CT scan bone window and digital X-rays flexion and extension not showing any instability at the cranio-vertebral junction
5.Ages between 15-65 years of age
6.Patient agrees to participate in the study
1.Presence of instability at the cranio-vertebral junction as demonstrated by CT scan bone window (sagittal sections) and digital X-rays
2.Presence of severe medical co-morbidity which may preclude surgery (cardio-vascular, osteoporosis, coagulation disorder etc.)
3.Patient has problem involving the spine either at cervical, thoracic or lumbar spine which may require a spine surgery with or without spine fixation elsewhere
4.Patient has other congenital anomalies
5.Pregnancy which may preclude full investigations
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method One surgical technique being better than the anotherTimepoint: Primary outcome will be assessed at the end of study i.e. after 3 years
- Secondary Outcome Measures
Name Time Method to look for the degree of neurological improvement as mentioned in the sheet <br/ ><br>To look for QOL improvementTimepoint: Will be done at 2 time points, 1 week post op and 6 months post op