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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Skull Defect

Study type: Observational

Funder types: Other

Identifiers

NCT05416684

IIT-2021-0111

Details and patient eligibility

About

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.

Enrollment: 358 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

358 participants in 2 patient groups

PEEK Group

Titanium Mesh Group