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

June 13, 2022 updated by: Junfeng Feng, RenJi Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

358

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with skull defect

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
PEEK Group
Titanium Mesh Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Failure
Time Frame: 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.
Within 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

May 28, 2022

First Submitted That Met QC Criteria

June 8, 2022

First Posted (Actual)

June 13, 2022

Study Record Updates

Last Update Posted (Actual)

June 16, 2022

Last Update Submitted That Met QC Criteria

June 13, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIT-2021-0111

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skull Defect

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe