Ponto Implantation Using a Minimally Invasive Surgical Technique

Hearing Loss Clinical Trial

Official title:

Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique - a Prospective Multicentre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606823
• Other study ID #: BC108
• Status: Completed
• Phase: N/A
• Start date: November 4, 2020
• Est. completion date: April 26, 2023

Study information

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

Clinical Trial Summary

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

The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique.

Description:

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

The purpose of the study is to investigate the rate of successful BAHS use after implantation of the Ponto implant system using a minimally invasive surgical technique. 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 three months after implantation/surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: April 26, 2023
• Est. primary completion date: August 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Patient indicated for surgical intervention with a bone anchored hearing system

• Signed informed consent

• Adequate bone quality to allow for a Ponto implant insertion, as judged by the investigator, and an expected bone thickness above 5 mm, where no complications during surgery are expected

• Skin thickness of 12 mm or less at the implant site

Exclusion Criteria:

• Patient undergoing re-implantation

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

• Known condition or previous treatment that could jeopardize skin condition and wound healing over time as judged by the investigator (e.g. uncontrolled diabetes, previous radiotherapy in the area of interest)

• Known medical condition that contraindicate surgery as judged by the investigator

• Known and/or planned pregnancy at time of surgery

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

• Simultaneous participation in another clinical investigation with pharmaceutical and/or medical device which might cause interference with investigation participation

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Procedure:
• Minimally invasive surgery
The subjects will be implanted with a bone anchored hearing system using a minimally invasive surgery.

Other:
• Glasgow Benefit Inventory (GBI)
A quality of life-questionnaire is to be completed by the subjects at one occasion.
• Additional follow-up visits after surgery
There are 1-3 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
Netherlands	Univerisity Medical Center Groningen	Groningen
Netherlands	Radboud University Medical Center	Nijmegen
Sweden	Sahlgrenska University Hospital	Gothenburg
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
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,  Netherlands,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety outcome - Adverse events	Number and severity of adverse events related to the investigational device and corresponding procedures.	12 months after surgery
Other	Safety outcome - Device deficiences	Number and severity of device deficiencies.	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 overgrowth 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, skin overgrowth or 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 overgrowth and pain preventing use of the sound processor. For a positive outcome (reliable anchorage), the implant should be in place and stable without any adverse skin reactions, skin overgrowth or 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 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 distribution	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	Max Holgers score	Max Holgers score rating (scale 0-4) per patient across study visits, where a higher score corresponds to a poorer outcome, assigned by investigator.	12 months after implant surgery
Secondary	Mild/Adverse skin reaction	Mild/Adverse skin reaction per patient across study visits, where adverse skin reaction is defined as Holgers = 2 on at least one follow-up visit.	12 months after implant surgery
Secondary	IPS (Inflammation, Pain, Skin height) scores	Distribution of IPS scores (Inflammation score 0-4; Pain score 0-2; Skin height score 0-2) 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	Wound healing	Investigator assessment of wound being completely healed by means of a Yes/No question.	12 months after implant surgery
Secondary	Skin dehiscence	Prevalence of skin dehiscence around the abutment measured as millimeters of dehiscence.	12 months after implant surgery
Secondary	Skin overgrowth	Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question.	12 months after implant surgery
Secondary	Post-operative events around abutment	Assessment of post-operative events by the investigator.	12 months after implant surgery
Secondary	Patient-perceived presence of pain around 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 abutment	Assessment of magnitude of patient-perceived pain using a numerical rating scale (range 0-10), where a higher rating corresponds to a poorer outcome.	12 months after implant surgery
Secondary	Patient-perceived presence of numbness around abutment	Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient.	12 months after implant surgery
Secondary	Patient-perceived magnitude of numbness around abutment	Assessment of magnitude of patient-perceived numbness using a numerical rating scale (range 0-10), where a higher rating corresponds to a poorer outcome.	12 months after implant surgery
Secondary	Duration of surgery	Length of surgery measured in minutes.	3 months after implant surgery
Secondary	Sound processor usage	Average sound processor usage time.	12 months after implant surgery
Secondary	Subjective benefit after 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 surgery