Synthetic Cranioplasty PEEK Versus UHMWP

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cranium; Deformity

Intervention / Treatment
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* Device: UHMWP Cranioplasty
* Device: PEEK Cranioplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UHMWP Cranioplasty<br>synthetic reconstruction of cranial defects using computer guided milled UHMWP implants | Device: UHMWP Cranioplasty<br>* patient specific cranial implant<br>|
| Active Comparator: PEEK Cranioplasty<br>synthetic reconstruction of cranial defects using computer guided milled PEEK | Device: PEEK Cranioplasty<br>* patient specific cranial implant<br>|

What is the study measuring?
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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 |