BioComp Implants in Anaplastology - Pilot Study

Maastricht University Medical Centre (MUMC)

Status: Unknown

Conditions: Craniofacial Defects; Prostheses and Implants

Treatments: Device: HAVD-implant

Study type: Interventional

Funder types: Other

Identifiers

NCT02444962

METC142065

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

HAVD implant

Experimental group

Treatment:

Device: HAVD-implant