BioComp Implants in Anaplastology - Pilot Study

NCT02444962 | Unknown DMC

• 1 other identifier: METC142065
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostheses and Implants; Craniofacial Defects

Outcome Measures

Primary Outcomes (1)

• Changes in implant stability as measured by the Osstell implant stability meter at one year

  one year

Secondary Outcomes (9)

• 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

Study Arms (1)

HAVD implant

EXPERIMENTAL

Device: HAVD-implant

Interventions

HAVD-implant DEVICE

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

HAVD implant

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In need of an auricular, nasal or orbital episthesis
• Be able to maintain a good personal hygiene

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

MaastrichtUMC

Maastricht, Limburg, 6229HX, Netherlands

RECRUITING

Study Officials

• Peter AW Kessler, Prof. Dr.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronique CM Timmer, Msc

CONTACT

+31433872010; v.timmer@mumc.nl

Lucas J Poort, Drs

CONTACT

+31433872010; l.poort@mumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: May 15, 2015
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: November 27, 2018

Record last verified: 2018-11

Locations

NL (1)