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| Name | Class |
|---|---|
| Statistiska Konsultgruppen | OTHER |
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A bone anchored hearing system is used to improve hearing for patients with e.g. conductive/mixed hearing loss or single sided deafness.
With this type of system, a titanium implant is installed in the temporal bone, where it osseointegrates, i.e. integrates with the bone. An abutment (also in titanium) is attached to the implants and penetrates the skin. The sound processor (hearing aid) is then connected to the abutment, and can be attached and removed by the patient via a snap-coupling. This type of system has been successfully implanted in more than 100.000 patients. Recently, a simplified surgical procedure, where no skin thinning around the abutment is made, was approved. The results after using this installation technique, here called soft tissue preservation, are the focus of this study.
The objective of the study is to compare the outcomes after a surgical procedure with soft tissue preservation (test) and a surgery with soft tissue reduction (control) for placing Oticon Medical Ponto implants and abutments. The main hypothesis is that patient numbness around the implant is less in the test group compared to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tissue preservation | Ponto implant installed using a tissue preservation surgical technique | ||
| Tissue reduction | Ponto implant installed using a classical technique with skin thinning |
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| Measure | Description | Time Frame |
|---|---|---|
| Numbness around implant, specifically mean Total sensibility | 36 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Length of surgery | At surgery | |
| Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient | 0-6 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Skin height around abutment (in mm) | At surgery | |
| Skin height around abutment (in mm) | 7 days post surgery | |
| Skin height around abutment (in mm) |
Inclusion Criteria:
Exclusion Criteria:
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All patients to be included are already planned for treatment with a bone anchored hearing aid at Radboud University Nijmegen Medical Centre (Nijmegen, The Netherlands).
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| Name | Affiliation | Role |
|---|---|---|
| Myrthe KS Hol, MD, PhD | Radboud University Medical Center | Principal Investigator |
| Emmanuel AM Mylanus, MD, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Centre | Nijmegen | 6500 HB | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26945315 | Background | den Besten CA, Bosman AJ, Nelissen RC, Mylanus EA, Hol MK. Controlled Clinical Trial on Bone-anchored Hearing Implants and a Surgical Technique With Soft-tissue Preservation. Otol Neurotol. 2016 Jun;37(5):504-12. doi: 10.1097/MAO.0000000000000994. |
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| D046089 | Hearing Loss, Mixed Conductive-Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Mild/Adverse skin reaction |
Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period Holgers score is a standardized score of skin reactions around a bone anchored hearing implant. |
| 0-6 months |
| Skin condition according to Holgers | Holgers score is a standardized score of skin reactions around a bone anchored hearing implant. | 7 days after surgery |
| Postoperative complications | Including
| 7 days to 6 months |
| Proportion of patients with complete wound healing at first surgical visit | 7 days |
| Glasgow Benefit Inventory (GBI) scores | 3 months |
| Glasgow Health Status Inventory (GHSI) scores | Baseline (before surgery) |
| Abbreviated profile of hearing aid benefit (APHAB) scores | Baseline (before surgery) |
| Mean hours of use of the sound processor | 0-6 months |
| Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient | 0-12 months |
| Sum of number of unplanned visits, revision surgeries, medications related to implant, and other treatments requiring medical staff per patient | 0-36 months |
| Bone conduction (BC) in-situ audiometric thresholds | 6 months |
| Bone conduction (BC) audiometric threshold | Measured with B-71 | 6 months |
| Mean total sensibility around implant | Baseline (before surgery) |
| Implant stability quotient (ISQ) | At surgery |
| Time to implant loss | 0-36 months |
| Patient and Observer scar assessment score | 21 days post surgery |
| Mild/Adverse skin reaction | Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period | 0-12 months |
| Mild/Adverse skin reaction | Adverse skin reaction is defined as a Holgers score ≥ 2 at least one follow-up visit, including unplanned visits, during the analysis period | 0-36 months |
| Skin condition according to Holgers | 21 days |
| Skin condition according to Holgers | 12 weeks |
| Skin condition according to Holgers | 6 months |
| Skin condition according to Holgers | 1 year |
| Skin condition according to Holgers | 2 years |
| Skin condition according to Holgers | 3 years after surgery |
| Postoperative complications | Including
| 7 days to 12 months |
| Postoperative complications | Including
| 7 days to 36 months |
| Glasgow Benefit Inventory (GBI) scores | 12 months |
| Glasgow Health Status Inventory (GHSI) scores | 6 months |
| Glasgow Health Status Inventory (GHSI) scores | 36 months |
| Abbreviated profile of hearing aid benefit (APHAB) scores | 6 months |
| Abbreviated profile of hearing aid benefit (APHAB) scores | 36 months |
| Mean hours of use of the sound processor | 0-36 months |
| Mean total sensibility around implant | 21 days |
| Mean total sensibility around implant | 6 months |
| Mean total sensibility around implant | 12 months |
| Mean total sensibility around implant | 36 months |
| Implant stability quotient (ISQ) | 7 days post surgery |
| Implant stability quotient (ISQ) | 21 days post surgery |
| Implant stability quotient (ISQ) | 12 weeks post surgery |
| Implant stability quotient (ISQ) | 6 months post surgery |
| Implant stability quotient (ISQ) | 12 months post surgery |
| Implant stability quotient (ISQ) | 24 months post surgery |
| Implant stability quotient (ISQ) | 36 months post surgery |
| Patient and Observer scar assessment score | 6 months |
| Patient and Observer scar assessment score | 12 months |
| Patient and Observer scar assessment score | 36 months |
| 21 days post surgery |
| Skin height around abutment (in mm) | 12 weeks post surgery |
| Skin height around abutment (in mm) | 6 months post surgery |
| Skin height around abutment (in mm) | 12 months post surgery |
| Skin height around abutment (in mm) | 36 months post surgery |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |