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| Name | Class |
|---|---|
| Cochlear Bone Anchored Solutions | INDUSTRY |
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A single centre, open, comparative, parallel group, prospective clinical investigation with a single 10 year follow up visit.
This study is a continuation of two previous conducted trials:
Stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation new BIA300 (test) implant vs previous generation (control) implant:
3 weeks loading: stability, long term survival and tolerability of a novel Baha® implant system, a multi-centre investigation 3 week loading vs 6+ week loading (= same group as control group trial 1). 6- month(4) and 3-year(5) data.
In this study the (5-year data for trial 2 and) 10-year data regarding stability, survival and soft tissue tolerability from the above mentioned trials will be evaluated and compared. The previous trials were multicentre, but the current study will be single-centred and therefore only include the participants of the Radboud site. Data will be collected at a visit at (5 years, for trial 2 and) 10 years (+/- 6 months) after implantation.
Up to now, no RCT of these implants (with the loading of 3 weeks after implantation) has assessed stability, survival and tolerability over a 10-year follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control implant loaded at 6 weeks post-surgery | Active Comparator | The control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment. |
|
| Test implant loaded at 6 weeks post-surgery | Experimental | The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment. |
|
| Test implant loaded at 3 weeks post-surgery | Experimental | The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment | Device | The control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment. |
| Measure | Description | Time Frame |
|---|---|---|
| implant stability | Implant Stability Quotiënt (ISQ) will be measured at the 10y-visit. The resonance frequency analysis renders an ISQ value ranging from 1 to 100. Measurements shall be performed at the abutment level, as is done in the previous investigations. The highest and lowest ISQ value out of two perpendicular measurements shall be recorded as ISQ High and ISQ low. The measurement should preferably be done by the same Osstell instrument (Osstell, Gothenburg, Sweden) that was used in the previous completed study. SmartPeg Type 43 and 55 shall be used during the measurement (Osstell, Gothenburg, Sweden). The procedures for obtaining ISQ values is described in the manufacturer's instruction that will be handed out to the investigators. | 10 years after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| implant survival | All patients will be asked if they have experienced any implant osseointegration problems. The time from implantation until implant loss or removal will be noted. In case of implant removal, reason for removal shall be recorded. | 10 years after implantation |
| soft tissue reaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | 6525EX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36417764 | Background | Teunissen EM, Caspers CJI, Vijverberg MA, Mylanus EAM, Hol MKS. Long-Term Follow-up of a Wide-Diameter Bone-Anchored Hearing Implant: 10-Year Experience on Stability, Survival, and Tolerability of an Implant-Abutment Combination. Otol Neurotol. 2023 Jan 1;44(1):40-46. doi: 10.1097/MAO.0000000000003763. Epub 2022 Nov 23. |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
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| Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment | Device | The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment. In addition to the difference in abutment shape and the wider diameter, the test implant incorporates small-sized threads at the implant neck and the moderately rough TiOblast™ (Dentsply, Mölndal, Sweden) surface on the intraosseous part of the implant6-8. |
|
| Early loading | Procedure | Loading the implant at 3 weeks after implantation (instead of 6 weeks after implantation) |
|
Soft tissue reactions will be measured using the Holgers' classification & IPS-score. The Holgers' classification is designed to capture signs and symptoms of inflammation or infection at the site of implantation (scale 0-4). The IPS-score is a complete standardized assessment scale for skin complications for both percutaneous and transcutaneous implants for bone conduction devices (BCDs) with a proposed treatment advice based on the outcome. The IPS score has three subscales: inflammation (0-4); pain (0-2), and skin height (0-2). |
| 10 years after implantation |
| device use | To evaluate the long-term device use of a Baha®. | 10 years after surgery |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |