Evaluating PEEK vs. Titanium Cranioplasty for Skull Defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the effectiveness of PEEK and titanium materials used in cranioplasty for patients with skull defects. It will compare the rates of implant failure, including infections and complications, within 12 months post-surgery. Additionally, the study will evaluate neurological function recovery at 3, 6, and 12 months after the procedure. The research will involve monitoring patients who have undergone cranioplasty to gather data on outcomes and complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Skull defect with a diameter greater than 3cm
* No intracranial hemorrhage, intracranial hypertension or hydrocephalus (or treated) occurred more than 1 month after the previous operation
* Cranioplasty is feasible according to doctor's evaluation
* Patients must agree to participate in this clinical trial and the informed consent is signed by patients themselves or next of kin on behalf of the patient.

Exclusion Criteria:

* Manifestations of intracranial hypertension or untreated hydrocephalus
* Poor healing of skin wound
* Intracerebral infection or intracerebral hematoma is not cured
* Patients with operational contradictions, for example, poor general condition

Where it's running

• Renji Hospital, School of Medicine, Shanghai Jiao Tong University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Zhiyi Zhou
• Email: zzyhenry@sina.com
• Phone: 15921055766

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.