Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC(RECEPT-DC)

ConditionSkull Defect
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorRenJi Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

358 Participants
are grouped into 2 trial groups

Sponsors and collaborators