Synthetic Cranioplasty PEEK Versus UHMWP

NCT ID: NCT05250024

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2023-07-21

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.

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.

Conditions

Cranium; Deformity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UHMWP Cranioplasty

synthetic reconstruction of cranial defects using computer guided milled UHMWP implants

Group Type: EXPERIMENTAL

UHMWP Cranioplasty

Intervention Type: DEVICE

patient specific cranial implant

PEEK Cranioplasty

synthetic reconstruction of cranial defects using computer guided milled PEEK

Group Type: ACTIVE_COMPARATOR

PEEK Cranioplasty

Intervention Type: DEVICE

patient specific cranial implant

Interventions

UHMWP Cranioplasty

patient specific cranial implant

Intervention Type: DEVICE

PEEK Cranioplasty

patient specific cranial implant

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mariam SK Abdelwahed

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mamdouh A Sayed, Professor

Role: STUDY_DIRECTOR

Cairo University

Locations

Nasser Institute Hospital

Cairo, Shubra, Egypt

Countries

Egypt

Other Identifiers

CRANIOPEEK/UHMWP

Identifier Type: -

Identifier Source: org_study_id