Ponto Implantation Using a Minimally Invasive Surgical Technique

• ClinicalTrials.gov Identifier: NCT04606823
• Recruitment Status: Recruiting
• First Posted: October 28, 2020
• Last Update Posted: November 23, 2021
• Sponsor: Oticon Medical
• Information provided by (Responsible Party): Oticon Medical

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Hearing Loss	Procedure: Minimally invasive surgery; Other: Glasgow Benefit Inventory (GBI); Other: Additional follow-up visits after surgery	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique - a Prospective Multicentre Study
• Actual Study Start Date: November 4, 2020
• Estimated Primary Completion Date: April 2022
• Estimated Study Completion Date: January 2023

Arms and Interventions

Arm

Intervention/treatment

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).

Outcome Measures

Primary Outcome Measures :

1. Implant/abutment complex capability to provide a reliable anchorage for a sound processor [ Time Frame: 3 months after implant surgery ]
   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.

Secondary Outcome Measures :

1. Implant/abutment complex capability to provide reliable anchorage for sound processor [ Time Frame: 12 months after implant surgery ]
   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.
2. Implant survival [ Time Frame: 12 months after implant surgery ]
   Implant survival will be assessed by the investigator by means of a Yes/No question: Implant in place [Yes/No]
3. Implant stability [ Time Frame: 12 months after implant surgery ]
   Clinical assessment of implant stability by the investigator by means of a Yes/No question: Implant stable [Yes/No]
4. Holgers score distribution [ Time Frame: 12 months after implant surgery ]
   Distribution of Holgers score ratings (scale 0-4), where a higher score corresponds to a poorer outcome, assigned by investigator.
5. Max Holgers score [ Time Frame: 12 months after implant surgery ]
   Max Holgers score rating (scale 0-4) per patient across study visits, where a higher score corresponds to a poorer outcome, assigned by investigator.
6. Mild/Adverse skin reaction [ Time Frame: 12 months after implant surgery ]
   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.
7. IPS (Inflammation, Pain, Skin height) scores [ Time Frame: 12 months after implant surgery ]
   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.
8. Wound healing [ Time Frame: 12 months after implant surgery ]
   Investigator assessment of wound being completely healed by means of a Yes/No question.
9. Skin dehiscence [ Time Frame: 12 months after implant surgery ]
   Prevalence of skin dehiscence around the abutment measured as millimeters of dehiscence.
10. Skin overgrowth [ Time Frame: 12 months after implant surgery ]
    Skin overgrowth over implant/abutment complex judged by the investigator by means of a Yes/No question.
11. Post-operative events around abutment [ Time Frame: 12 months after implant surgery ]
    Assessment of post-operative events by the investigator.
12. Patient-perceived presence of pain around abutment [ Time Frame: 12 months after implant surgery ]
    Assessment of presence of patient-perceived pain by means of a Yes/No question to the subject.
13. Patient-perceived magnitude of pain around abutment [ Time Frame: 12 months after implant surgery ]
    Assessment of magnitude of patient-perceived pain using a numerical rating scale (range 0-10), where a higher rating corresponds to a poorer outcome.
14. Patient-perceived presence of numbness around abutment [ Time Frame: 12 months after implant surgery ]
    Assessment of presence of patient-perceived numbness by means of a Yes/No question to the patient.
15. Patient-perceived magnitude of numbness around abutment [ Time Frame: 12 months after implant surgery ]
    Assessment of magnitude of patient-perceived numbness using a numerical rating scale (range 0-10), where a higher rating corresponds to a poorer outcome.
16. Duration of surgery [ Time Frame: 3 months after implant surgery ]
    Length of surgery measured in minutes.
17. Sound processor usage [ Time Frame: 12 months after implant surgery ]
    Average sound processor usage time.
18. Subjective benefit after surgery [ Time Frame: 3 months 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.

Other Outcome Measures:

1. Safety outcome - Adverse events [ Time Frame: 12 months after surgery ]
   Number and severity of adverse events related to the investigational device and corresponding procedures.
2. Safety outcome - Device deficiences [ Time Frame: 12 months after surgery ]
   Number and severity of device deficiencies.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Sara Svensson, PhD; +46735042041; ssve@oticonmedical.com

Locations

Denmark

Aalborg University Hospital; Recruiting

Aalborg, Denmark, 9000

Contact: Dan Dupont Hougaard, MD

Odense University Hospital; Withdrawn

Odense, Denmark, 5000

Netherlands

Univerisity Medical Center Groningen; Recruiting

Groningen, Netherlands

Contact: Myrthe Hol, MD

Radboud University Medical Center; Recruiting

Nijmegen, Netherlands, 6525EX

Contact: Myrhe Hol, MD

Sweden

Sahlgrenska University Hospital; Recruiting

Gothenburg, Sweden, 413 46

Contact: Måns Eeg Olofsson, MD

United Kingdom

University Hospitals Birmingham NHS Foundation Trust; Recruiting

Birmingham, United Kingdom, B15 2WB

Contact: Rupan Banga, MD

Cambridge University Hospitals NHS Foundation Trust; Recruiting

Cambridge, United Kingdom, CB2 0QQ

Contact: James Tysome, MD

Guy's and St Thomas' NHS Foundation Trust; Recruiting

London, United Kingdom, SE1 7EH

Contact: Harry Powell, MD

Sponsors and Collaborators

Oticon Medical

Investigators

• Principal Investigator: Harry Powell, MD; Guy's and St Thomas' NHS Foundation Trust

More Information

• Responsible Party: Oticon Medical
• ClinicalTrials.gov Identifier: NCT04606823
• Other Study ID Numbers: BC108
• First Posted: October 28, 2020
• Last Update Posted: November 23, 2021
• Last Verified: November 2021

• 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

Additional relevant MeSH terms:

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases