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Synthetic Cranioplasty PEEK Versus UHMWP

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05250024
Enrollment
22
Registered
2022-02-22
Start date
2021-11-30
Completion date
2023-07-21
Last updated
2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cranium; Deformity

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.

Interventions

DEVICEUHMWP Cranioplasty

patient specific cranial implant

patient specific cranial implant

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cosmetic patient satisfaction6 monthsMethod: Questionnaire, Satisfaction Scale \[ 1 Dissatisfied - 5 Highly satisfied \]

Secondary

MeasureTime frameDescription
Overall complications6 monthsMethod: Clinical exam, Unit: Binary Y/N
implant failure6 monthsMethod: Clinical exam, Unit: Binary Y/N

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026