Multi-Centre Study on the Performance of the Ponto BHX Implant System (in Adult Patients)

Hearing Loss Clinical Trial

Official title:

A Prospective Multi-Centre Study on the Performance of the Ponto BHX Implant System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04310202
• Other study ID #: Doc-00066211
• Status: Active, not recruiting
• Start date: January 17, 2021
• Est. completion date: January 31, 2024

Study information

• Verified date: August 2023
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto Biohelix (BHX) Implant system.

Description:

This multi-centre study funded by Oticon Medical AB will be conducted at seven hospitals across Europe (UK, Spain, Denmark). Patients with a hearing loss and that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (BAHS) will be included in the study. A total of 50 patients will be included in the study.

The purpose of this study is to investigate the rate of successful BAHS use after implantation of the Ponto BHX Implant system. The implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. The primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor, 3 months after implantation/surgery.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 31, 2024
• Est. primary completion date: April 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Patients indicated for surgical intervention with a bone anchored hearing system according to local clinic's standard guidelines

• Adequate bone quality to allow for a Ponto BHX implant insertion, as judged by the investigator, and an expected bone thickness above 3 mm, where no complications during surgery are expected

Exclusion Criteria:

• Patients undergoing re-implantation

• Patients who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales.

• Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus

• Known conditions (e.g. uncontrolled diabetes) that could jeopardize skin condition and wound healing over time as judged by the investigator

• Any other known condition that the investigator determines could interfere with compliance or study assessments

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Other:
• Abbreviated Profile of Hearing Aid Benefit (APHAB)
An intervention in this study which is outside the routine clinical practice of the clinics is the APHAB questionnaire that will be completed by the subjects on two occasions.
• Glasgow Benefit Inventory (GBI)
An intervention in this study which is outside the routine clinical practice of the clinics is the GBI questionnaire that will be completed by the subjects on two occasions.
• Additional follow-up visits after surgery
There are 1-2 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Rigshospitalet	Copenhagen
Spain	Hospital Universitario de Donostia	San Sebastián	Gipuzkoa
Spain	Hospital Clinico Universitario de Valencia	Valencia
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Countries where clinical trial is conducted

Denmark,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety outcome	Occurrence and severity of adverse events related to the investigational device and corresponding procedures	12 months after surgery
Primary	Implant/abutment complex capability to provide a reliable Anchorage for a sound processor	The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable. without any adverse skin reactions or skin over-growth and pain preventing usage of the sound processor.	3 months after implant surgery
Secondary	Implant/abutment complex capability to provide reliable anchorage for sound processor	The variables assessed to determine reliable anchorage in the study are implant survival and stability, skin reactions, skin over-growth and pain preventing use of the sound processor. For a positive outcome of the primary endpoint (reliable anchorage), the implant should be in place and stable without any adverse skin reactions or skin over-growth and pain preventing usage of the sound processor.	12 months after implant surgery
Secondary	Implant survival	Implant survival will be assessed by the investigator by means of a Yes/No question: Implant/abutment complex in place [Yes/No]	12 months after implant surgery
Secondary	Implant stability	Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable [Yes/No]	12 months after implant surgery
Secondary	Holgers score ratings	Distribution of Holgers score ratings (scale 0-4) where a higher score corresponds to a poorer outcome, assigned by investigator	12 months after implant surgery
Secondary	IPS (Inflammation, Pain, Skin height) scores	Distribution of IPS (Inflammation [total score 0-4], Pain [score 0-2], Skin height [score 0-2]) scores assigned by investigator. The IPS score is presented as [Ix Px Sx] with x being the individual score for each parameter. A higher score corresponds to a poorer outcome	12 months after implant surgery
Secondary	Patient-perceived presence of pain around implant/abutment	Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject	12 months after implant surgery
Secondary	Patient-perceived magnitude of pain around implant/abutment	Assessment of magnitude of patient-perceived pain using a numerical rating scale (NRS) (range 0-10) where a higher rating corresponds to a poorer outcome	12 months after implant surgery
Secondary	Patient-perceived presence of numbness around implant/abutment	Assessment of presence of patient-perceived numbness by means of a Yes/No question to the subject	12 months after implant surgery
Secondary	Patient-perceived magnitude of numbness around implant/abutment	Assessment of magnitude of patient-perceived numbness using a numerical rating scale (NRS) (range 0-10) where a higher rating corresponds to a poorer outcome	12 months after implant surgery
Secondary	Skin/soft tissue overgrowth	Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question	12 months after implant surgery
Secondary	Duration of surgery	Length of surgery measured in minutes	At implant surgery
Secondary	Wound dehiscence	Prevalence of wound dehiscence measured as millimeters of dehiscence	12 months after implant surgery
Secondary	Wound healing time	Average healing time [days] from surgery when the wound is considered healed	12 months after implant surgery
Secondary	Implant/abutment usage	Mean hours of use of a sound processor on the implant/abutment	12 months after implant surgery
Secondary	Subjective benefit after implant surgery	Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a global higher score corresponds to a poorer outcome	At screening visit (visit before surgery)
Secondary	Subjective benefit after implant surgery	Abbreviated Profile Hearing Aid Benefit (APHAB) questionnaire score (1-99) where a global higher score corresponds to a poorer outcome	6 months after implant surgery
Secondary	Subjective benefit after implant surgery	Glasgow Benefit Inventory (GBI) questionnaire score (-100 to +100) where [-100] means maximum adverse effect, [0] means no effect, and [+100] means maximum positive effect	3 months after implant surgery
Secondary	Subjective benefit after implant surgery	Glasgow Benefit Inventory (GBI) questionnaire score (-100 to +100) where [-100] means maximum adverse effect, [0] means no effect, and [+100] means maximum positive effect	12 months after implant surgery