NCT06662903

Brief Summary

The aim of this study is: To compare the surgical outcomes between titanium mesh and bone cement in cranioplasty. To assess the complication rates associated with each material. To evaluate patient satisfaction and aesthetic results post-surgery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

October 1, 2024

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

1.4 years

First QC Date

October 25, 2024

Last Update Submit

October 25, 2024

Conditions

Bone DefectsDecompressive Craniectomy and CranioplastyCranioplasty

Keywords

CranioplastyTitanium meshBone cementTraumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction using patient ssatisfaction grade

    Patients satisfaction (cosmetic, psychological, neurologic ) measered by validate questionnaire post-opeartive and follow up using Patient satisfaction grade from Excellent to not satisfied

    through study completion, an average 1 years

Secondary Outcomes (4)

  • Infection

    through study completion, an average 1 years

  • Reoperation

    through study completion, an average 1 years

  • CSF leak

    through study completion, an average 1 years

  • complications

    through study completion, an average 1 years

Study Arms (2)

Titanium mesh

ACTIVE COMPARATOR

this group is operated using titanium mesh

Procedure: Cranioplasty with Titanium mesh

Bone cement

ACTIVE COMPARATOR

this group is operated using bone cement

Procedure: Cranioplasty with bone cement

Interventions

Cranioplasty with Titanium meshPROCEDURE

Cranioplasty using titanium mesh

Titanium mesh
Cranioplasty with bone cementPROCEDURE

Cranioplasty using bone cement

Bone cement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring cranioplasty for a skull defect due to Decompressive Craniectomy, trauma, tumor resection, or congenital issues.
  • All ages .
  • Both sex.
  • Informed consent obtained from all participants.
  • Patient fit for surgery.

You may not qualify if:

  • Patients with active infection at the surgical site
  • Patient Unfit for surgery.
  • Patient refuse consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University Hospital

Asyut, Asyut Governorate, Egypt

Location

Related Publications (5)

  • Mousa M, Eissa S, Raslan M, Abu ElNaga B, Balaha A. Evaluation of three different methods of cranioplasty; a comparative prospective randomized study. Pan Arab Journal of Neurosurgery. 2021;16

    BACKGROUND

  • Andrabi SM, Sarmast AH, Kirmani AR, Bhat AR. Cranioplasty: Indications, procedures, and outcome - An institutional experience. Surg Neurol Int. 2017 May 26;8:91. doi: 10.4103/sni.sni_45_17. eCollection 2017.

    PMID: 28607825BACKGROUND

  • Capitelli-McMahon H, Kahlar N, Rahman S. Titanium Versus Autologous Bone-Based Cranioplasty: A Systematic Review and Meta-Analysis. Cureus. 2023 May 26;15(5):e39516. doi: 10.7759/cureus.39516. eCollection 2023 May.

    PMID: 37366436BACKGROUND

  • Aydin S, Kucukyuruk B, Abuzayed B, Aydin S, Sanus GZ. Cranioplasty: Review of materials and techniques. J Neurosci Rural Pract. 2011 Jul;2(2):162-7. doi: 10.4103/0976-3147.83584.

    PMID: 21897681BACKGROUND

  • Alkhaibary A, Alharbi A, Alnefaie N, Oqalaa Almubarak A, Aloraidi A, Khairy S. Cranioplasty: A Comprehensive Review of the History, Materials, Surgical Aspects, and Complications. World Neurosurg. 2020 Jul;139:445-452. doi: 10.1016/j.wneu.2020.04.211. Epub 2020 May 6.

    PMID: 32387405BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Bone Cements

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Resins, SyntheticPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

Osman Hassan Zafraan, Resident doctor

CONTACT

+201220993578docosmanhassan@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Titanium mesh VS Bone cement in Cranioplasty
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

October 25, 2024

First Posted

October 29, 2024

Study Start

October 1, 2024

Primary Completion

March 1, 2026

Study Completion

May 1, 2026

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations

EG(1)