NCT05416684 Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）
| NCT ID | NCT05416684 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Skull Defect |
| Study Type | OBSERVATIONAL |
| Enrollment | 358 participants |
| Start Date | 2024-11-07 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 358 participants in total. It began in 2024-11-07 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this trial is to scientifically evaluate the efficacy of PEEK cranioplasty and titanium cranioplasty. The primary objective is to compare the rate of implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty. The secondary objective is to compare the complication rates and neurological function recover following cranioplasty. Complication events after cranioplasty are investigated within 6 months after surgery and neurological function is evaluated at 3, 6 and 12 months after cranioplasty.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05416684 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Skull Defect. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05416684 currently recruiting?
Yes, NCT05416684 is actively recruiting participants. Contact the research team at zzyhenry@sina.com for enrollment information.
Where is the NCT05416684 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05416684 clinical trial?
NCT05416684 is sponsored by RenJi Hospital. The trial plans to enroll 358 participants.