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
1 other identifier
observational
358
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2022
CompletedFirst Posted
Study publicly available on registry
June 13, 2022
CompletedStudy Start
First participant enrolled
November 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
November 12, 2024
November 1, 2024
2.9 years
May 28, 2022
November 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Length of stay in hospital
Within 2 months post-operation
Detailed Economic Evaluation
Within 6 months post-operation
Complications Rates
3, 6, and 12 months
Glasgow coma scale (GCS)
3, 6, and 12 months
Glasgow outcome scale (GOS)
3, 6, and 12 months
- +2 more secondary outcomes
Study Arms (2)
PEEK Group
Titanium Mesh Group
Eligibility Criteria
Patients with skull defect
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Brain Injury Center
Study Record Dates
First Submitted
May 28, 2022
First Posted
June 13, 2022
Study Start
November 7, 2024
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
September 30, 2027
Last Updated
November 12, 2024
Record last verified: 2024-11