Evaluation of titanium cranioplasty and polyetheretherketone craniopalsty after decompressive craniectomy for traumatic brain injury: a prospective, multicenter, non-randomized controlled trial.

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000033406

Enrollment

Unknown

Registered

2020-05-31

Start date

2020-06-01

Completion date

Unknown

Last updated

2020-06-01

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

Conditions

cranial defect

Interventions

experimental group:PEEK cranioplasty

control group:titanium cranioplasty

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Diagnosed with cranial defect; 2) Patients aged over 16 years; 3) Decompressive craniectomy after traumatic brain injury; 4) The defect size is over 25 cm2; 5) Aagree to participate in the clinic trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Bilateral cranial defect; 2) Hypertensitivity to metals; 3) With uncontrolled intracranial infection; 4) With unhealed wounds; 5) Suspicion of hydrocephalus.

Design outcomes

Primary

Measure	Time frame
implant failure rate;	—

Secondary

Measure	Time frame
complication;Glasgow outcome scale;MMSE;motor function;	—

Countries

China

Contacts

Public ContactJunwen Guan

West China Hospital, Sichuan University

guanjunwen_scu@163.com+86 18980605821

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026