Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-31 @ 4:14 AM
Study NCT ID:
NCT05058066
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2021-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
10-year Follow-up of a Wide Diameter Bone Anchored Hearing Implant
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057893', 'term': 'Immediate Dental Implant Loading'}], 'ancestors': [{'id': 'D003758', 'term': 'Dental Implantation, Endosseous'}, {'id': 'D003757', 'term': 'Dental Implantation'}, {'id': 'D013516', 'term': 'Oral Surgical Procedures, Preprosthetic'}, {'id': 'D019647', 'term': 'Oral Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011476', 'term': 'Prosthodontics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2021-09-16', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'implant stability', 'timeFrame': '10 years after implantation', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'implant survival', 'timeFrame': '10 years after implantation', 'description': '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.'}, {'measure': 'soft tissue reaction', 'timeFrame': '10 years after implantation', 'description': "Soft tissue reactions will be measured using the Holgers' classification \\& IPS-score.\n\nThe Holgers' classification is designed to capture signs and symptoms of inflammation or infection at the site of implantation (scale 0-4).\n\nThe 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)."}, {'measure': 'device use', 'timeFrame': '10 years after surgery', 'description': 'To evaluate the long-term device use of a Baha®.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Loss']}, 'referencesModule': {'references': [{'pmid': '36417764', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'A single centre, open, comparative, parallel group, prospective clinical investigation with a single 10 year follow up visit.', 'detailedDescription': 'This study is a continuation of two previous conducted trials:\n\n1. 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:\n\n 1. CAG5173: 6-month(1) and 3-year(2) data.\n 2. CBAS5562: 5-year data(3).\n2. 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.\n\nIn 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.\n\nUp 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be included in the original trials, patients had to be at least 18 years old.\n\nExclusion Criteria:\n\n* Exclusion criteria were an inability to follow investigational procedures, any factor at the discretion of the investigator that was considered to contraindicate participation, and any disease or treatment known to compromise the bone quality at the implant site. For patients who had lost or removed the implant, the time to implant loss was recorded. Patients who could not attend the 5 or 10 year follow-up visit for other reasons were included in the implant survival analysis as well; the last available information regarding implant survival was obtained verbally from the patient, from medical records, or from information captured from the original investigations. Furthermore, patients were excluded if they had a bone thickness less than 4 mm at the implant site during implantation.'}, 'identificationModule': {'nctId': 'NCT05058066', 'briefTitle': '10-year Follow-up of a Wide Diameter Bone Anchored Hearing Implant', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Long-term Follow-up of a Wide Diameter Bone Anchored Hearing Implant: the 10-year Experience on Stability, Survival and Tolerability of the BIA300®', 'orgStudyIdInfo': {'id': 'CAG5173/CBAS5562 10y'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control implant loaded at 6 weeks post-surgery', 'description': 'The control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment.', 'interventionNames': ['Device: Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment']}, {'type': 'EXPERIMENTAL', 'label': 'Test implant loaded at 6 weeks post-surgery', 'description': '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.', 'interventionNames': ['Device: Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment']}, {'type': 'EXPERIMENTAL', 'label': 'Test implant loaded at 3 weeks post-surgery', 'description': '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.', 'interventionNames': ['Device: Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment', 'Procedure: Early loading']}], 'interventions': [{'name': 'Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment', 'type': 'DEVICE', 'description': 'The control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment.', 'armGroupLabels': ['Control implant loaded at 6 weeks post-surgery']}, {'name': 'Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Test implant loaded at 3 weeks post-surgery', 'Test implant loaded at 6 weeks post-surgery']}, {'name': 'Early loading', 'type': 'PROCEDURE', 'description': 'Loading the implant at 3 weeks after implantation (instead of 6 weeks after implantation)', 'armGroupLabels': ['Test implant loaded at 3 weeks post-surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6525EX', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cochlear Bone Anchored Solutions', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}