Prostheses and Implants Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | MaastrichtUMC | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
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 |
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