implant stability local skin reactions
Conditions
Interventions
None listed
Sponsors
Cochlear BAS
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The patient must meet the following criteria to be included; • Adult patients, i.e. >=18 years • Written informed consent • Eligible for the Baha system • Bone thickness at the implant site of at least 4 mm • Eligible for implantation with the two fixtures; 3,75 alternatively 4,5 mm wide • No known disease or treatment that compromises / will compromise the bone quality at the implant site
Exclusion criteria
Exclusion criteria: The patient should meet none of the following criteria • Unable to follow investigational procedures • Simultaneous participation in another investigation with pharmaceuticals and/or devices • Any factor, at the discretion of the investigator that is considered to contraindicate participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy variables RFA measurements will be done from time 0, visit 1, and onwards. The RFA measurements will be done with the abutment in place. The Smartpeg will be fastened to the abutment with a torque wrench standardising the momentum to 10 Ncm. The measurement will then be done. The RFA measurement results in ISQ values reflecting the stability of the fixture. The ISQ values will be recorded in three directions parallel to the skull; one horizontal from the front pointing backwards, two vertical; from above pointing down and one from below pointing upwards (see Appendix 5 for Instructions for use of the RFA equipment). Each ISQ recording may provide one or two values. Two values will result if the equipment detects differences in the ISQ value in its analysis of the fixture stability between two directions and thus cannot present just one value. In these instances will both values be recorded. The ISQ value ranges from 1 to 100. A higher value reflects a more stable fixture. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy variables Loss of the implant will be recorded from visit 2, day 10, onwards. Loss of the implant is defined as actual loss of the implant from the site of implantation. If this occurs between planned visits to the clinic patients will be encouraged to contact the clinic to record the event, but also to receive treatment according to the clinical routine, and to be withdrawn from the study. Loss of the Implant / fixture is a study end point. Local reactions like infection may lead to the explantation of the fixture. This is also defined as a study end point and will be recorded accordingly. The number of patients at each visit with implant survival will be reported. Data from visits in-between planned visits will be captured on the extra CRF pages provided. Loading of the Baha sound processor at 6 weeks post implant will be recorded using the ISQ values. | — |
Countries
Netherlands
Outcome results
None listed