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| ID | Type | Description | Link |
|---|---|---|---|
| CIV-ID 25-01-051014 | Other Identifier | Swedish Medical Products Agency |
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This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.
The study is observational and non interventional and follows clinical practice at participating clinics with the only exception of three questionnaires given to consenting patients after surgery and during follow-up, after loading of the sound processor.
The study is a combined retro- and prospective study. The retrospective part consists of a chart review of patients who have undergone Ponto-implantation out of OR from 2019 and onwards. The prospectively recruited subjects are patients who are planned to undergo Ponto-implantation surgery out-of-OR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective group | Data gathered from retrospective chart reviews of patients who have undergone Ponto-implantation in an out-of-OR setting from 2019 and onwards |
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| Prospective group | Patients who have undergone Ponto implantation in an out-of-OR setting and participated in the study by filling out questionnaires. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ponto implantation | Device | Ponto implantation is a surgical procedure to implant a bone-anchored hearing device, improving hearing by transmitting sound directly to the inner ear through bone conduction. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complications at surgery | During the Ponto-implantation surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of procedure room variables | To make an assessment of how procedure rooms that are used for Ponto out-of-OR surgeries look like. Will be measured using the 'Procedure room used for Out-of-OR Ponto-surgery questionnaire' | 12 months after study start |
| To assess surgical parameters |
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Inclusion Criteria:
Exclusion Criteria:
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Bone-conduction hearing device users
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Al-Dalal | Contact | +46 70-149 25 03 | srld@oticonmedical.com | |
| Sara Svensson | Contact | +46735042041 | ssve@oticonmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr David Morris | Queen Elizabeth II Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern California Veterans Affairs Healthcare System | Recruiting | Sacramento | California | 95655 | United States |
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With this outcome, the aim is to assess the surgical variables present during Ponto out-of-OR surgeries. A series of yes or no questions will be presented in a form to the surgeon regarding the use of anesthesia, sedatives, implants, and abutments of different lengths. The results will be presented in a table. |
| During Ponto-implantation surgery |
| Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire | Score is reported on a scale of 5 steps, were the lowest value (1) is the worst and the highest value is the best (5) | 5-10 days after Ponto surgery |
| To assess postoperative events and complications | All postoperative events and complications will be presented in a descriptive table, listing how many were affected by each type of event or complication. | From day of surgery, through study completion, an average of 1 year |
| To assess rate of implant survival | Implant survival will be assessed at least once, at 3 months. If follow-up data is available, implant survival will be assessed through study completion, an average of 1 year. | 3 months after surgery, and through study completion, an average of 1 year. |
| To assess time from surgery to sound processor loading | Time from surgery to sound processor loading which happens at an average of 3 months after surgery. |
| To assess sound processor usage time | 3 months after surgery, and through study completion, an average of 1 year. |
| To assess effectiveness of hearing rehabilitation using IOI-HA questionnaire | Will be assessed using the standardised questionnaire International Outcome Inventory for Hearing Aids (IOI-HA) score at 3 months post-surgery. In the questionnaire, each item has five response choices proceeding from the worst outcome to the best outcome (1-5). The score will be presented as mean score with, standard deviation and median for the two groups. | 3 months after surgery |
| To assess patient-reported benefit after BAHS treatment using the questionnaire Glasgow Benefit Inventory (GBI) | Glasgow Benefit Inventory (GBI) benefit scores will be presented for total-, general-, social- and physical scores at 3 months post-surgery. The GBI uses a scale from -100 to +100, where scores above 0 indicate improved quality of life. | 3 months after surgery |
| Clinical Hospital from the Ribeirão Preto Medical School | Active, not recruiting | São Paulo | São Paulo | 3900 | Brazil |
| Queen Elizabeth II Health Sciences Centre | Recruiting | Halifax | Nova Scotia | B3H 2Y9 | Canada |
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| Hospital Virgen de las Nieves | Active, not recruiting | Granada | Andalusia | 18014 | Spain |
| Sunderby Sjukhus | Active, not recruiting | Luleå | Norrbotten County | 971 80 | Sweden |
| Skåne University Hospital | Active, not recruiting | Lund | Skåne County | 22185 | Sweden |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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