BioComp Implants in Anaplastology - Pilot Study

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

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.

Study Overview

• Status: Unknown
• Conditions: Prostheses and Implants; Craniofacial Defects
• Intervention / Treatment: Device: HAVD-implant

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6229HX
      • Recruiting
      • MaastrichtUMC
      • Contact: Peter Kessler, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Peter AW Kessler, Prof. Dr., Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: May 12, 2015
• First Posted (Estimate): May 15, 2015

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 23, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: METC142065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No