Bone Conduction Deafness, Middle Ear Deafness, Mixed Hearing Loss, Unilateral Deafness
Conditions
Brief summary
The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.
Interventions
Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.
Sponsors
Oticon Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older. * Patient indicated for an ear level bone anchored sound processor. * Healthy bone quality to allow for 4mm implant insertion.
Exclusion criteria
* Intraoperative switch to an alternative surgical technique * Patients undergoing re-implantation (on the side being included in the study) * Previous participation in the C47 study. * 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. * Patients with natural skin height of \>12mm (as there will be additional skin reduction needed)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numbness (sensibility) around the implant | 6 months post surgery | Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned visits | 36 months | Investigate and compare the number of unplanned visits, including unplanned surgical procedures and other treatments for the test (this investigation) and control group (previous investigation, C47). |
| Adverse skin reactions | 36 months | Investigate and compare the rate of adverse skin reactions using the Holgers Scale. |
| Pain perception by patient | 36 months | Investigate and compare pain using a visual analogue scale 0-10 |
| Implant survivability | 36 months | Investigate and compare implant survivability in terms of reported implant loss. |
| Length of surgery | At surgery | Compare the surgical time between test (this investigation) and control group (previous investigation, C47). |
| Surgical wound healing time | 36 months | Investigate and compare healing time after surgery. Follow-up visits after surgery will assess the healing of wound. This will be a yes/no assessment to be answered by the attending physician. The investigators will also evaluate skin reactions and record any medications that were given to aid in skin healing. |
| Wound dehiscence | 36 months | Investigate wound dehiscence size after surgery. |
| Quality of Life Assessment | 36 months | Investigate and compare subjective benefit as measured by SSQ questionnaire. |
| Implant stability as measured with resonance frequency analysis, RFA. | 36 months | Investigate and compare implant stability. Implant stability is monitored by measuring the implant stability quotient when following up on patients. Stability will be reported as implant stability quotient (ISQ). |
Countries
Netherlands
Outcome results
None listed