Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
- Conditions
- DeafnessOtorhinolaryngologic DiseasesHearing Loss, ConductiveHearing LossHearing DisordersEar Diseases
- Interventions
- Device: Bone anchored hearing implant
- Registration Number
- NCT01738490
- Lead Sponsor
- Oticon Medical
- Brief Summary
The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery. Patients' quality of life improvements following implantation will also be surveyed.
More specifically the primary objective of this clinical study is to test the hypothesis
* The new Ponto wide diameter implant offers increased implant stability measured as ISQ (implant stability quotient) compared to the previous generation Ponto implant.
And the secondary objective is to
* Investigate when in time implant stability is the lowest as the initial mechanical stability is gradually replaced by biological stability
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- 18 years or older
- Patient indicated for an ear level bone anchored sound processor
- Bone thickness at the implant site of at least 4 mm
- Longer abutment (>6mm) required
- Inability to participate in follow-up
- Psychiatric disease in the medical history
- Mental disability
- Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
- Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Wide diameter implant Bone anchored hearing implant Bone anchored hearing implant For the wide diameter arm (test group), the Ponto wide implant (diameter 4,5mm, length 4mm) and abutment 6mm developed by Oticon Medical AB (Gothenburg, Sweden) will be installed. Control group Bone anchored hearing implant Bone anchored hearing implant For the control group, the previous generation Ponto implant (diameter 3,75mm, length 4mm) and 6mm abutment (Oticon Medical AB, Gothenburg, Sweden) will be installed.
- Primary Outcome Measures
Name Time Method ISQ (Implant Stability Quotient) 36 months after surgery
- Secondary Outcome Measures
Name Time Method Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire 36 months after surgery Glasgow Health Status Inventory (GHSI) questionnaire 36 months after surgery ISQ (Implant stability quotient) gradient 0, 7, 14, 21 and 28 days, 6 weeks, 12weeks, 6 months after surgery ISQ (implant stability quotient) per time unit gives a measure of osseointegration speed.
Skin condition according to Holgers score 36 months after surgery Glasgow Benefit Inventory Questionnaire 12 months after surgery Time of minimum ISQ (Implant stability quotient) 0, 7, 14, 21 and 28 days after surgery Implant stability can be seen as a combination of mechanical stability, which is the result of compressed bone holding the implant tightly in place, and biological stability, which is the result of new bone forming at the site of implantation and osseointegration. Mechanical stability is generally high immediately after implant placement and is decreasing with time. Biological stability, on the other hand, is non-existent immediately after placement and increases with time. The final stability level for an implant is the sum of the two. There is likely to be an initial decrease in stability followed by a subsequent increase as the implant becomes biologically stable. ISQ (implant Stability Quotient) is a measurement scale for use with the Resonance Frequency Analysis (RFA) method of determining implant stability.
Trial Locations
- Locations (1)
University Medical Center St Radboud
🇳🇱Nijmegen, Netherlands