Ponto Implantation Using a Minimally Invasive Surgical Technique

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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Procedure: Minimally invasive surgery; Other: Glasgow Benefit Inventory (GBI); Other: Additional follow-up visits after surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital
• Netherlands
  • Groningen, Netherlands
    • Univerisity Medical Center Groningen
  • Nijmegen, Netherlands, 6525EX
    • Radboud University Medical Center
• Sweden
  • Gothenburg, Sweden, 413 46
    • Sahlgrenska University Hospital
• United Kingdom
  • Birmingham, United Kingdom, B15 2WB
    • University Hospitals Birmingham NHS Foundation Trust
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Foundation Trust
  • London, United Kingdom, SE1 7EH
    • Guy's and St Thomas' NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single-arm; In this single-arm study the patients will be undergoing a minimally invasive surgery after which they will re-visit the clinic at five occasions for follow-up visits (1-3 extra compared to routine clinical practice at the hospitals) and complete a quality of life-questinnaire three months after surgery.

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.; Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Wound healing	Investigator assessment of wound being completely healed by means of a Yes/No question.	12 months after implant surgery
Skin dehiscence	Prevalence of skin dehiscence around the abutment measured as millimeters of dehiscence.	12 months after implant surgery
Skin overgrowth	Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question.	12 months after implant surgery
Post-operative events around abutment	Assessment of post-operative events by the investigator.	12 months after implant surgery
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
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
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
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
Duration of surgery	Length of surgery measured in minutes.	3 months after implant surgery
Sound processor usage	Average sound processor usage time.	12 months after implant surgery
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome - Adverse events	Number and severity of adverse events related to the investigational device and corresponding procedures.	12 months after surgery
Safety outcome - Device deficiences	Number and severity of device deficiencies.	12 months after surgery

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Principal Investigator: Harry Powell, MD, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2020
• Primary Completion (Actual): August 9, 2022
• Study Completion (Actual): April 26, 2023

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: BC108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No