Synthetic Cranioplasty PEEK Versus UHMWP

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

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.

Study Overview

• Status: Completed
• Conditions: Cranium; Deformity
• Intervention / Treatment: Device: UHMWP Cranioplasty; Device: PEEK Cranioplasty

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Shubra
    • Cairo, Shubra, Egypt
      • Nasser institute Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UHMWP Cranioplasty; synthetic reconstruction of cranial defects using computer guided milled UHMWP implants	Device: UHMWP Cranioplasty; patient specific cranial implant
Active Comparator: PEEK Cranioplasty; synthetic reconstruction of cranial defects using computer guided milled PEEK	Device: PEEK Cranioplasty; patient specific cranial implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cosmetic patient satisfaction	Method: Questionnaire, Satisfaction Scale [ 1 Dissatisfied - 5 Highly satisfied ]	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall complications	Method: Clinical exam, Unit: Binary Y/N	6 months
implant failure	Method: Clinical exam, Unit: Binary Y/N	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mamdouh A Sayed, Professor, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): July 21, 2023
• Study Completion (Actual): July 21, 2023

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: CRANIOPEEK/UHMWP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes