NCT04707404

Brief Summary

Decompressive craniectomy is suggested as an effective surgical intervention for patients with high intracranial pressure. Recently, various customized artificial materials are increasingly employed, e.g., titanium and polyetheretherketone (PEEK). The application of PEEK in cranioplasty is increasing, while its comprehensive evaluation in clinical practice is still insufficient, especially when comparing with the effects of titanium implant. We thus designed the study to evaluate the comprehensive effects of the cranioplasty with PEEK vs titanium.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

3.7 years

First QC Date

January 12, 2021

Last Update Submit

January 12, 2021

Conditions

Brain InjuriesHematoma of HeadSkull Defect

Keywords

CranioplastyPEEKTitaniumOutcomesComplicationsSubcutaneous effusion

Outcome Measures

Primary Outcomes (1)

  • Complications

    Postoperative complications including Incision infection, Subcutaneous infection, Postoperative hematoma, Subcutaneous effusion, New seizure, Implants exposure and Implants removal.

    December 2016 to December 2020

Secondary Outcomes (1)

  • Postoperative cranial symmetry

    December 2016 to July 2020

Other Outcomes (2)

  • Postoperative improvement of GOSE score

    December 2016 to Decemeber 2020

  • Postoperative feelings

    May 2017 to Decemeber 2020

Study Arms (2)

PEEK

Cranioplasty patients with PEEK.

Procedure: Cranioplasty

Titanium

Cranioplasty patients with titanium mesh.

Procedure: Cranioplasty

Interventions

CranioplastyPROCEDURE

The surgery implanted artificial material to repair the skull defect.

PEEKTitanium

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients received cranioplasty with PEEK and titanium from December 2016 to July 2020 in Renji hospital.

You may qualify if:

  • Patients underwent cranioplasty with PEEK or Titanium.
  • Patients underwent cranioplasty and had complete data and 6-month follow-up records.

You may not qualify if:

  • Patients underwent cranioplasty with other material or ABF.
  • Patients had incomplete data or follow-up records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 13, 2021

Study Start

December 1, 2016

Primary Completion

July 31, 2020

Study Completion

December 31, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01