Clinical trial NCT02444962: BioComp Implants in Anaplastology - Pilot Study
Official title: Safe and Easy Application of BioComp Implants for Prosthetic Reconstruction of Craniofacial Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostheses and Implants
Craniofacial Defects
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in implant stability as measured by the Osstell implant stability meter at one year
timeFrame: one year
Secondary outcomes:
measure: redness/irritation of the skin
timeFrame: baseline
measure: redness/irritation of the skin
timeFrame: 12 weeks after implant placement
measure: redness/irritation of the skin
timeFrame: 26 weeks after implant placement
measure: redness/irritation of the skin
timeFrame: 52 weeks after implant placement
measure: Implant survival
timeFrame: 52 weeks after implant placement
measure: Clinical ease of use
timeFrame: Directly after implant placement (0)
measure: Patient satisfaction as measured by a VAS scoring system
timeFrame: 26 weeks after implant placement
measure: Patient satisfaction as measured by a VAS scoring system
timeFrame: 52 weeks after implant placement
measure: Quality of life a measured by a VAS scoring system
timeFrame: 52 weeks after implant placement
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: MaastrichtUMC
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Peter AW Kessler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: