BioComp Implants in Anaplastology - Pilot Study

Prostheses and Implants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02444962
• Other study ID #: METC142065
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: November 2018
• Source: Maastricht University Medical Center
• Contact: Veronique CM Timmer, Msc
• Phone: +31433872010
• Email: v.timmer[@]mumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Craniofacial Defects
• Prostheses and Implants

Intervention

Device:
• HAVD-implant
hydroxy-apatite coated, acid etched implant for extra oral use to reconstruct craniofacial defects with an episthesis

Locations

Country	Name	City	State
Netherlands	MaastrichtUMC	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in implant stability as measured by the Osstell implant stability meter at one year		one year
Secondary	redness/irritation of the skin		baseline
Secondary	redness/irritation of the skin		12 weeks after implant placement
Secondary	redness/irritation of the skin		26 weeks after implant placement
Secondary	redness/irritation of the skin		52 weeks after implant placement
Secondary	Implant survival		52 weeks after implant placement
Secondary	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)
Secondary	Patient satisfaction as measured by a VAS scoring system	Patient satisfaction scored by a self made questionnaire	26 weeks after implant placement
Secondary	Patient satisfaction as measured by a VAS scoring system	Patient satisfaction scored by a self made questionnaire	52 weeks after implant placement
Secondary	Quality of life a measured by a VAS scoring system	Quality of life scored by a self made questionnaire	52 weeks after implant placement