Comparing two surgical techniques for Chiari malformation treatment
Type of Surgical Intervention for Chiari Malformation-syringomyelia: a Multicenter Randomized Controlled Study
NA · Xuanwu Hospital, Beijing · NCT06079125
This study is testing which of two surgical methods works better for people with Chiari malformation type I and syringomyelia to improve their health and quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 352 (estimated) |
| Ages | 14 Years to 80 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing (other) |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06079125 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of posterior fossa decompression and duraplasty with or without tonsil manipulation in patients with Chiari malformation type I and syringomyelia. Participants will be randomly assigned to one of the two surgical approaches and will undergo follow-up assessments at 3-6 months, 12 months, and 24 months post-surgery. These assessments will include physical exams, symptom reporting, and MRI scans to monitor outcomes and complications. The goal is to determine which approach leads to better patient outcomes and quality of life.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 and older with Chiari malformation type I and syringomyelia meeting specific MRI criteria.
Not a fit: Patients with preexisting conditions such as hydrocephalus, tumors, or those who have had prior posterior fossa surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients with Chiari malformation type I.
How similar studies have performed: While similar surgical approaches have been explored, this specific comparison of techniques in Chiari malformation treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing
- Fengzeng Jian — Beijing, Beijing, China (RECRUITING)
Study contacts
- Study coordinator: fengzeng jian, M.D.
- Email: jianfengzeng@xwh.ccmu.edu.cn
- Phone: +861083198899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chiari Malformation Type I, Tonsillectomy, posterior fossa decompression with duraplasty, tonsillectomy, FMDD