PFDD Versus PFDRT in Chiari Decompression Surgery

Not Applicable

Recruiting

• Conditions: Chiari Malformation Type I; Tonsillectomy

• Registration Number: NCT06079125
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

The purpose of this study is to determine whether a posterior fossa decompression and duraplasty with or without tonsil manipulation results in better patient outcomes with fewer complications and improved quality of life in those who have Chiari malformation type I and syringomyelia.

Detailed Description

Participants with Chiari Malformation type I and syringomyelia will be randomized to either have a posterior fossa decompression and duraplasty with or without tonsil manipulation. The participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: 3-6 months, 12 and 24 months. At these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete questionnaires. A spine MRI will be performed 3-6 months, 12 and 24 months after the decompression.

Study Timeline

• Study First Submitted: 2023-08-20
• Status Verified: 2023-10
• Study Start: 2023-10
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Study First Posted: 2023-10-12
• Last Update Posted: 2023-10-12
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 352

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
improvement or resolution of the syrinx,	3-6, 12 and 24 months	defined as \> 50% improvement in length, maximal cross-sectional diameter, or both.

Secondary Outcome Measures

Name	Time	Method
visual analog scale (VAS)	12 months	degree of the pain
complication rates	12 months	Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications
Japanese Orthopaedic Association (JOA) scale	12 months	Japanese Orthopaedic Association Scores
blood loss	12 months	blood loss
hospital stay	12 months	hospital stay
cost for the hospitalisation.	12 months	cost for the hospitalisation.
Chicago Chiari Outcome Scale (CCOS) scale	12 months

Trial Locations

Locations (1)

Fengzeng Jian; 🇨🇳 Beijing, Beijing, China