Is instrumented fixation of the cranio-vertebral junction a better treatment for Chiari Malformation with or without syrnix

PROSPECTIVE RANDOMIZED TRIAL TO COMPARE THE EFFICACY OF FORAMEN MAGNUM DECOMPRESSION WITH DURAPLASTY VS POSTERIOR INSTRUMENTED FIXATION FOR CHIARI MALFORMATION - CMRCT

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018751

Enrollment

100

Registered

2019-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G988- Other disorders of nervous system

Interventions

Intervention1: group b: will undergo c1-c2 fixation Intervention2: group a: will undergo foramen magnum decompression with duraplasty Control Intervention1: clinical profile: post op clinical profile

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
One surgical technique being better than the anotherTimepoint: Primary outcome will be assessed at the end of study i.e. after 3 years	—

Secondary

Measure	Time frame
to look for the degree of neurological improvement as mentioned in the sheet To look for QOL improvementTimepoint: Will be done at 2 time points, 1 week post op and 6 months post op	—

Countries

India

Contacts

Public ContactDr Simranjeet Singh

All India Institute of Medical Sciences

saratpchandra3@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026