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Chiari malformation type I treatment: comparison between Resection of Filum Terminale and Posterior Fossa Decompression

Evaluation of patient-reported outcome in the treatment of Chiari Malformation type I in adults without tethered cord with Resection of the Filum Terminale versus Posterior Fossa Decompression: randomized non-inferiority clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-10crngzr
Enrollment
Unknown
Registered
2026-01-05
Start date
2024-05-01
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Arnold-Chiari Malformation

Interventions

This is an open-label, two-arm, non-inferiority controlled clinical trial to evaluate patient-reported outcomes after 6 months of surgical treatment of Chiari malformation type 1 in adults without tet

Sponsors

Hospital Universitário Onofre Lopes
Lead Sponsor
Universidade São Paulo
Collaborator
Faculdade de Ciências Médicas - Unicamp
Collaborator
Hospital Universtário Universidade Federal do Maranhão Presidente Dutra
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: age over 18 on the day of recruitment; have a radiological diagnosis of Chiari type I without tethered cord and clinical symptoms resulting from Chiari; free informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Exclusion criteria will be: being under 18 years of age, failure to agree to a free and informed consent form, presence of radiological signs of tethered spinal cord, and diagnosis of psychiatric illness without regular treatment, since pre- and post-operative evaluations will include subjective complaints. Presence of symptoms or radiological signs of tethered spinal cord; diagnosis of psychiatric illness without regular treatment, since pre- and post-operative evaluations will include subjective complaints; previous neurological or spinal surgeries.

Design outcomes

Primary

MeasureTime frame
It is expected that measures of central tendency on the Chicago Chiari Outcome Scale will be similar between the groups.—

Secondary

MeasureTime frame
It is expected that measures of central tendency of the European Quality of Life 5-dimension 3-level scale score index will be similar between the groups;It is expected that measures of central tendency of the Short-form 12 items quality of life assessment will be similar between the groups;Complication rates (mortality, fistula, and infection) are expected to be lower in the experimental group—

Countries

Brazil

Contacts

Public ContactGuilherme Lima

Hospital Universitário Onofre Lopes

guilhermelimaneurocirurgia@gmail.com+55(84)98889-3185

Outcome results

None listed

Source: REBEC (via WHO ICTRP)