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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05416684

Enrollment

358

Registered

2022-06-13

Start date

2024-11-07

Completion date

2027-09-30

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skull Defect

Keywords

Skull Defect, Epilepsy, Infections

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Length of stay in hospital	Within 2 months post-operation	The duration of hospitalization after operation.
Mini-Mental State Examination score (MMSE)	3, 6, and 12 months	—
Appearance Satisfaction	6 months	Questionnaire was used to investigate patients' satisfaction with the appearance of cranioplasty.
Glasgow outcome scale (GOS)	3, 6, and 12 months	—

Countries

China

Contacts

Primary ContactZhiyi Zhou

zzyhenry@sina.com15921055766

Outcome results