BioComp Implants in Anaplastology - Pilot Study

Not Applicable

• Conditions: Prostheses and Implants; Craniofacial Defects
• Interventions: Device: HAVD-implant

• Registration Number: NCT02444962
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2015-05-12
• Study First Posted: 2015-05-15
• Study Start: 2018-06-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-23
• Last Update Posted: 2018-11-27
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HAVD implant	HAVD-implant	-

Primary Outcome Measures

Name	Time	Method
Changes in implant stability as measured by the Osstell implant stability meter at one year	one year

Secondary Outcome Measures

Name	Time	Method
Clinical ease of use	Directly after implant placement (0)	Opinion of the surgeon about the easiness of use of the implant system, scored by a questionnaire.
redness/irritation of the skin	52 weeks after implant placement
Implant survival	52 weeks after implant placement
Patient satisfaction as measured by a VAS scoring system	52 weeks after implant placement	Patient satisfaction scored by a self made questionnaire
Quality of life a measured by a VAS scoring system	52 weeks after implant placement	Quality of life scored by a self made questionnaire

Trial Locations

Locations (1)

MaastrichtUMC; 🇳🇱 Maastricht, Limburg, Netherlands