3D Printed PEEK Implants for Cranioplasty

Study Overview
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Brief Summary
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This study is a non-randomised and single center study with patients needing an artificial skull bone eg cranioplasty. 40 patients will be implanted with in house manufactured polyether ether ketone (PEEK) implants using a fused filament fabrication 3D printer. The primary aim is to ascertain safety and feasibility of the procedure. The secondary aim is to compare complication rates with conventional methods such as autologous bone and polymethylmetacrylate (PMMA).

Detailed Description
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Cranioplasty is the surgical repair of a congenital or cranial defects after head trauma, infection or decompressive craniectomy. Although some patients can tolerate cranial defects for varied periods of time, cranioplasty is mostly indicated due to the increased risk of additional brain trauma, local pain or impaired CSF circulation but also aesthetic and psychological issues. The gold standard for repair since many years is cranioplasty with autologous bones . However, sometimes it not feasible to use the patient's autologous bone due to infections, trauma, bone graft resorption and donor-site morbidity. To replace the autologous bone grafts several different materials have been used, or are in use, as titanium meshes, hydroxyapatite cement and plastic resins as polymethyl methacrylate (PMMA) and porous polyethylene. Some of these have gathered increased interest due to advancements in technology for manufacture of these materials, and also the possibility to create custom made implants or moulds. The present study aims to assay safety and feasibility of in house 3D printed medical grade PEEK implants in research persons with acquired skull defects. The implants will be manufactured after 3D rendering from CT images of the skull defects, sterilised and aseptically inserted in the defects by means of a surgical intervention. A safety interim analysis will be performed after inclusion of 10 patients.

Official Title
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3D Printed PEEK Implants for Cranioplasty

Conditions
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Skull Defect

Intervention / Treatment
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* Device: PEEK Cranioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for cranioplasty Informed consent Exclusion Criteria: No informed consent Implant size greater than 12x12 cm

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, non randomised and single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cranioplasty PEEK<br> | Device: PEEK Cranioplasty<br>* 3D printed PEEK skull implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performed PEEK implants | Percentage of performed PEEK implants out of included patients. | At end of surgical procedure, up to 2 months after inclusion | 
| Safety of PEEK implants | Survival percentage of PEEK implants. Will be compared to historical PMMA and autologous bone implants. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure time of PEEK implants compared to PMMA implants. | Compare exposure time for PEEK implant during surgery with historical PMMA implants made in 3D printed mold. | During surgical procedure, up to 2 months after inclusion. | 
| Complications of PEEK implants | Complications after PEEK implants other than those leading to extraction of implant will be compared to historical PMMA and autologous bone implants. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEEK, Cranioplasty, 3D printer