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

Recruiting

• Conditions: Skull Defect

• Registration Number: NCT05416684
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-28
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Status Verified: 2024-11
• Study Start: 2024-11-07
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 358

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Implant Failure	Within 12 months	implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty.

Secondary Outcome Measures

Name	Time	Method
Glasgow outcome scale (GOS)	3, 6, and 12 months
Appearance Satisfaction	6 months	Questionnaire was used to investigate patients' satisfaction with the appearance of cranioplasty.
Length of stay in hospital	Within 2 months post-operation	The duration of hospitalization after operation.
Detailed Economic Evaluation	Within 6 months post-operation	Total medical expense related to treatment of cranioplasty, including the costs of operations and hospitalization within 6 months post-injury.
Complications Rates	3, 6, and 12 months	including seizure, hematoma, hydrocephalus, etc.
Glasgow coma scale (GCS)	3, 6, and 12 months	The Glasgow coma scale (GCS) is used to assess and calculate the patient's level of consciousness.
Mini-Mental State Examination score (MMSE)	3, 6, and 12 months

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China