Evaluating PEEK vs. Titanium Cranioplasty for Skull Defects
A Real World Prospective Observational Study on Evaluation the Comprehensive Effects of Polyetheretherketone Cranioplasty and Titanium Cranioplasty After Decompressive Craniectomy
RenJi Hospital · NCT05416684
This study is testing whether using PEEK or titanium for skull surgery helps patients recover better and have fewer problems after their operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 358 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | RenJi Hospital (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05416684 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with skull defects greater than 3cm who meet specific health criteria and can provide informed consent.
Not a fit: Patients with untreated intracranial hypertension, hydrocephalus, or poor healing conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and material selection for patients undergoing cranioplasty.
How similar studies have performed: While there have been studies on cranioplasty materials, this specific comparison of PEEK and titanium is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
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: Skull Defect, Epilepsy, Infections