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Completed

NCT Number: NCT05250024

Synthetic Cranioplasty PEEK Versus UHMWP

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.

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Key information

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nasser Institute Hospital

Cairo, Shubra, Egypt

About this study

Statement of the problem:

To this date, there is still no consensus on the ideal material for cranial reconstruction. Research journey involved the use of autologous grafts, allografts, xenografts, and a wide array of synthetic materials for cranioplasty. The autologous bone flap, although associated with less infection than allo or xenografts, is not always a possibility after comminution or osteomyelitis and still has the common drawbacks of storage, aseptic bone flap necrosis (ABFR) and the need for a second surgery. Titanium offers lower cost but is quite difficult to shape, radiopaque and exhibits high dehiscence with thin skin biotypes. Polyetheretherketone (PEEK) has been gaining popularity during the recent years for lower rates of graft failure, however, it still holds a risk of postoperative inflammatory complications, is of exceedingly high cost most studies utilizing it are retrospective and observational.

Rationale for conducting the research:

Cranioplasty procedures carry functional and esthetic challenges and the most suitable graft to be used remains controversial. UHMWP use in biomedical applications is greatly due to its outstanding mechanical properties and biocompatibility which, when coupled with three D computer guided milling technology to reconstruct complex and large cranial defects, can provide durable patient specific implants (PSI). However, no interventional studies exist in the literature on its application in cranioplasty.

Explanation for choice of comparators:

PEEK as a semicrystalline thermoplastic polymer has a thickness and elasticity comparable to cortical bone making it one of the most commonly used bone substitute materials and is currently recommended as a standard viable option for cranial defects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

UHMWP Cranioplasty

Device

patient specific cranial implant

PEEK Cranioplasty

Device

patient specific cranial implant

Primary outcomes

  1. Cosmetic patient satisfaction

    Time frame: 6 months

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

Secondary outcomes

  1. Overall complications

    Time frame: 6 months

    Method: Clinical exam, Unit: Binary Y/N

  2. implant failure

    Time frame: 6 months

    Method: Clinical exam, Unit: Binary Y/N

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Cranioplasty Using Patient Specific Implants Polyether Ether Ketone Versus Ultra-High Molecular Weight Polyethylene: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 22, 2022
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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