BioComp Implants in Anaplastology - Pilot Study

Study Overview
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Brief Summary
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At the department of Cranio-Maxillofacial Surgery, Maastricht University Medical Center (MUMC) the routine procedure after ablation of the nose, ear or eye is reconstruction with an episthesis. Retention can be achieved using adhesives, undercuts or bone implants. Implant based episthesis are now commonly used because of the good retention and episthesis stability. This results in a better patient quality of life. Today we use machined surface implants in the craniofacial region of different brands. Each system has its own instruments and application method. To enhance the clinical usability, we are searching for one system for all extra-oral implant regions. Furthermore, implant patients may be compromised by aging, diseases, smoking, medication and radiation therapy, which can affect the bone healing process. In these cases, implants are known to have higher failure rates compared to the application in healthy cases. Therefore implants with biomechanical surface modifications, such as the HAVD implants of BioComp, may have a positive effect on osseointegration, resulting in higher success rates in the compromised patient. The aim of this pilot study is to collect information about the functionality and safety of a surface treated implant system (HAVD, BioComp) for episthetic reconstruction after ablative surgery in the nasal, orbital and auricular region for a potential future RCT.

Official Title
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Safe and Easy Application of BioComp Implants for Prosthetic Reconstruction of Craniofacial Defects

Conditions
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Prostheses and Implants, Craniofacial Defects

Intervention / Treatment
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* Device: HAVD-implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In need of an auricular, nasal or orbital episthesis Be able to maintain a good personal hygiene Exclusion Criteria: Contraindications for general anesthesia DEmentia or other psychiatric disorders/ unable to maintain a good personal hygiene Poor personal hygiene Pregnancy Acute infection Immunosuppression Compromised by medication Local irradiation >50Gray

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HAVD implant<br> | Device: HAVD-implant<br>* hydroxy-apatite coated, acid etched implant for extra oral use to reconstruct craniofacial defects with an episthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in implant stability as measured by the Osstell implant stability meter at one year |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| redness/irritation of the skin |  | baseline | 
| redness/irritation of the skin |  | 12 weeks after implant placement | 
| redness/irritation of the skin |  | 26 weeks after implant placement | 
| redness/irritation of the skin |  | 52 weeks after implant placement | 
| Implant survival |  | 52 weeks after implant placement | 
| Clinical ease of use | Opinion of the surgeon about the easiness of use of the implant system, scored by a questionnaire. | Directly after implant placement (0) | 
| Patient satisfaction as measured by a VAS scoring system | Patient satisfaction scored by a self made questionnaire | 26 weeks after implant placement | 
| Patient satisfaction as measured by a VAS scoring system | Patient satisfaction scored by a self made questionnaire | 52 weeks after implant placement | 
| Quality of life a measured by a VAS scoring system | Quality of life scored by a self made questionnaire | 52 weeks after implant placement |