PFDD Versus PFDRT in Chiari Decompression Surgery

Launched by XUANWU HOSPITAL, BEIJING · Oct 9, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different surgical approaches for treating Chiari malformation type I, a condition where brain tissue extends into the spinal canal, often causing headaches and other symptoms. Specifically, the study will compare a surgery that involves decompressing the back of the skull and covering the area (called duraplasty) with one that also includes moving the tonsils. The goal is to see which approach leads to better recovery, fewer complications, and an improved quality of life for patients.

To participate in this trial, you need to be at least 14 years old and have a Chiari malformation with certain specific features, including a 5 mm or greater displacement of the tonsils and a type of fluid-filled cyst in the spine called syringomyelia. Before the surgery, participants will need to share MRI scans of their brain and spine. This study is open to all genders and is currently recruiting participants. If you decide to join, you can expect to undergo one of the two surgical procedures and will be monitored for improvements in your symptoms and overall well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥14 years old
• • Chiari malformation type I ≥5 mm tonsillar ectopia
• • a syrinx with a width \> 50% of the cross-sectional diameter of the spinal cord , and a length of at least 2 cervical and/or thoracic vertebral segments.
• • MRI of the brain and cervical and thoracic spine are required prior to surgery and must be available to be shared with the Data Coordinating Center
• Exclusion Criteria:
• • included one or more of the following preexisting conditions: hydrocephalus; tumor; brain trauma; stroke; meningitis; abscess;
• • other congenital anomalies of the brain or skull base; vertebral anomalies (i.e., Klippel-Feil, atlas assimilation, etc.);
• • degenerative or demyelinating disease;
• • CM-I without syringomyelia;
• • syringomyelia with cerebellar tonsils in a normal position;
• • fibromyalgia;
• • chronic fatigue syndrome;
• • prior posterior fossa surgery.
• • Unable to share pre-decompression MRI of the brain and spine Patients who do not wish to participate