NCT05250024

Brief Summary

The purpose of this study is to report the investigators experience with synthetic reconstruction of cranial defects using computer guided milled UHMWP, in terms of benefits and limitations both clinically and radiographically in comparison to PEEK implants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

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

November 30, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

January 31, 2022

Last Update Submit

August 31, 2023

Conditions

Cranium; Deformity

Outcome Measures

Primary Outcomes (1)

  • Cosmetic patient satisfaction

    Method: Questionnaire, Satisfaction Scale \[ 1 Dissatisfied - 5 Highly satisfied \]

    6 months

Secondary Outcomes (2)

  • Overall complications

    6 months

  • implant failure

    6 months

Study Arms (2)

UHMWP Cranioplasty

EXPERIMENTAL

synthetic reconstruction of cranial defects using computer guided milled UHMWP implants

Device: UHMWP Cranioplasty

PEEK Cranioplasty

ACTIVE COMPARATOR

synthetic reconstruction of cranial defects using computer guided milled PEEK

Device: PEEK Cranioplasty

Interventions

UHMWP CranioplastyDEVICE

patient specific cranial implant

UHMWP Cranioplasty
PEEK CranioplastyDEVICE

patient specific cranial implant

PEEK Cranioplasty

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cranial defect patients
  • Patients eligible for simultaneous craniectomy and cranioplasty.
  • ASA I \& II

You may not qualify if:

  • Active infection.
  • Medically compromised patients (ASA ≥3).
  • Hydrocephalus/Brain Swelling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nasser Institute Hospital

Cairo, Shubra, Egypt

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Mamdouh A Sayed, Professor

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 31, 2022

First Posted

February 22, 2022

Study Start

November 30, 2021

Primary Completion

July 21, 2023

Study Completion

July 21, 2023

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

EG(1)