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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally Invasive Ponto Surgery | Other | Surgical method for installation of a bone anchored hearing system for hearing rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally Invasive Ponto Surgery | Device | Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems. |
| Measure | Description | Time Frame |
|---|---|---|
| Numbness (sensibility) around the implant | Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility. | 6 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Length of surgery | Compare the surgical time between test (this investigation) and control group (previous investigation, C47). | At surgery |
| Unplanned visits | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myrthe Hol, MD, PhD | Radboud UMC, Department of Otorhinolaryngology. The Netherlands | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Center | Nijmegen | 6525 | Netherlands |
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| ID | Term |
|---|---|
| D046088 | Hearing Loss, Unilateral |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| 36 months |
| Adverse skin reactions | Investigate and compare the rate of adverse skin reactions using the Holgers Scale. | 36 months |
| Adverse skin reactions | Investigate and compare the rate of adverse skin reactions using the IPS scale. | 36 months |
| Pain perception by patient | Investigate and compare pain using a visual analogue scale 0-10 | 36 months |
| Implant survivability | Investigate and compare implant survivability in terms of reported implant loss. | 36 months |
| Implant stability as measured with resonance frequency analysis, RFA. | 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). | 36 months |
| Surgical wound healing time | 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. | 36 months |
| Wound dehiscence | Investigate wound dehiscence size after surgery. | 36 months |
| Quality of Life Assessment | Investigate and compare subjective benefit as measured by SSQ questionnaire. | 36 months |
| Quality of Life Assessment | Investigate and compare subjective benefit as measured by YORK questionnaire. | 36 months |
| Quality of Life Assessment | Investigate and compare subjective benefit as measured by APHAB questionnaire. | 36 months |
| Quality of Life Assessment | Investigate and compare subjective benefit as measured by GBI questionnaire. | 36 months |
| Quality of Life Assessment | Investigate and compare subjective benefit as measured by GHSI questionnaire. | 36 months |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |