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

Skull Defect Clinical Trial

Official title:

A Real World Prospective Observational Study on Evaluation the Comprehensive Effects of Polyetheretherketone Cranioplasty and Titanium Cranioplasty After Decompressive Craniectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05416684
• Other study ID #: IIT-2021-0111
• Status: Recruiting
• Start date: June 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2022
• Source: RenJi Hospital
• Contact: Zhiyi Zhou
• Phone: 15921055766
• Email: zzyhenry[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 358
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2023
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Skull Defect

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Failure	implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty.	Within 12 months
Secondary	Length of stay in hospital	The duration of hospitalization after operation.	Within 2 months post-operation
Secondary	Detailed Economic Evaluation	Total medical expense related to treatment of cranioplasty, including the costs of operations and hospitalization within 6 months post-injury.	Within 6 months post-operation
Secondary	Complications Rates	including seizure, hematoma, hydrocephalus, etc.	3, 6, and 12 months
Secondary	Glasgow coma scale (GCS)	The Glasgow coma scale (GCS) is used to assess and calculate the patient's level of consciousness.	3, 6, and 12 months
Secondary	Glasgow outcome scale (GOS)		3, 6, and 12 months
Secondary	Mini-Mental State Examination score (MMSE)		3, 6, and 12 months
Secondary	Appearance Satisfaction	Questionnaire was used to investigate patients' satisfaction with the appearance of cranioplasty.	6 months