Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Oticon Medical
- Enrollment
- 59
- Locations
- 2
- Primary Endpoint
- ISQ (Implant Stability Quotient)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Wide diameter 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.
Intervention: Bone anchored hearing implant (Device)
Control group
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.
Intervention: Bone anchored hearing implant (Device)
Outcomes
Primary Outcomes
ISQ (Implant Stability Quotient)
Time Frame: 36 months after surgery
Secondary Outcomes
- 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)
- 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)