Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty

Study Overview
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Brief Summary
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The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to infections, re-operations, antibiotic treatment or removal of the implant.

Detailed Description
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Both implant materials for cranioplasty, Hydroxylapatite and Titanium, are CE certified medical devices used in common practices. This study is intended to get prospective data in addition to the empirical and retrospective existing ones to enable the decision on which implant material should be preferably employed in future.

Official Title
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Comparison of Individual CAD/CAM-based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty - a Randomized Multicenter Clinical Trial

Conditions
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Skull Defects, Cranioplasty

Intervention / Treatment
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* Device: Titanium implant (CranioConstruct™)
* Device: Hydroxylapatite (CustomBone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skull defects without the possibility to be covered with the missing own bone Size of the defect ≥ 16 cm2 Age ≥ 18 Written informed consent of the patient Exclusion Criteria: Active tumor ASA 4 classification Allergic disposition to ceramic or titanium Concomitant participation in other clinical trials Pregnant or nursing women Expected low compliance HIV positive Active drug abuses

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Titanium<br>Titanium implant for cranioplasty. Titanium implants are used since 10 years in Germany because of their high biocompatibility and accuracy of fit. | Device: Titanium implant (CranioConstruct™)<br>* One to three weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Titanium implant is ordered.<br>* Other names: CranioConstruct™;|
| Experimental: Hydroxylapatite<br>Hydroxylapatite (CustomBone) implant Hydroxylapatite implants are used since about 3 years in Germany. As this material is very similar to human bone structure an improved osteointegration has been observed. | Device: Hydroxylapatite (CustomBone)<br>* Six to eight weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Hydroxylapatite implant is ordered.<br>* Other names: CustomBone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the rate of local and/or systemic infections (acute/chronic) in both study arms within the first 6 months after operation. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the rate of re-operations with and without ex-plantation of the implant in both arms. |  | 6 months | 
| Comparison of post-operative computer tomography (CT) (native and bone 5 mm) within 48 h in respect to bleeding, dislocation and further complications after cranioplasty in both arms. |  | 48 hours post-operative | 
| Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire. |  | 6 months | 
| Comparison between both groups referring to cosmetic result, period of hospitalization, costs, intra-operative features. |  | 6 months | 
| Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups. |  | 6 months | 
| Description of osteointegration with CT and bone scan six months post-operative in both groups |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skull defects, Hydroxylapatite implant, Titanium implant, calotte defects without the possibility to be covered with the missing own bone